<\/p>\n
The article is 2012-2013 based and reader discretion is sought to ascertian the stage of approval<\/h1>\nBreast Cancer Drugs in Late-Stage Development\/Recently\u00a0Approved<\/a><\/h2>\n <\/p>\n
![\"\"](\"http:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/a\/a1\/Everolimus.svg\/220px-Everolimus.svg.png\")
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\n\nAfinitor\u00ae (everolimus)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/04\/27\/drug-spotlight-afinitor-everolimus-novartis\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Novartis<\/p>\nMethod of Action:<\/strong>\u00a0Mammalian target of rapamycin (mTOR) inhibitor<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0Hepatocellular carcinoma; human epidermal growth factor receptor 2-positive (HER2+) breast cancer first-line and second-line; lymphoma; nonfunctional carcinoid tumor (Phase III; all new indications)<\/p>\nApproved in July in U.S., EU for advanced hormone-receptor-positive (HR+) and human epidermal growth factor Receptor 2-negative (HER2-) metastatic breast cancer with exemestane in postmenopausal women who have already received certain other medicines for their cancer<\/p>\n
Approved earlier for adults with pancreatic neuroendocrine tumors (PNET) that cannot be treated with surgery; adults with advanced renal cell carcinoma (RCC) when certain other medicines have not worked; adults with angiomyolipoma, seen with tuberous sclerosis complex (TSC), when surgery is not required immediately; and adults and children with TSC who have a brain tumor called subependymal giant cell astrocytoma (SEGA) that cannot be removed completely by surgery<\/p>\n<\/div>\n
\u00a0![\"\"](\"https:\/\/encrypted-tbn0.gstatic.com\/images?q=tbn:ANd9GcS38VfooVqiBwFP-zeJNaunkGEFoK9fZoRmv5goscXTYTv1Qgw5\")
<\/strong><\/h3>\n\nAvastin (Bevacizumab; RG435)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/02\/23\/fda-has-approved-a-new-use-of-avastin-bevacizumab-in-combination-with-fluoropyrimidine-based-irinotecan-or-oxaliplatin-chemotherapy-for-people-with-metastatic-colorectal-cancer-mcrc\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Roche\/Genentech<\/p>\nMethod of Action:<\/strong>\u00a0Monoclonal antibody; Vascular endothelial growth factor (VEGF) inhibitor<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0U.S.: Relapsed ovarian cancer, platinum-sensitive (Registration); first-line metastatic breast cancer and first-line metastatic ovarian cancer (both Phase III).<\/p>\nEU: Relapsed platinum-resistance ovarian cancer (Phase III)<\/p>\n
Metastatic colorectal cancer, treatment beyond progression (Registration); adjuvant breast cancer, HER2- and HER2+; adjuvant NSCLC; first-line glioblastoma (GBM) multiforme; high-risk carcinoid (all Phase III)<\/p>\n
Approved for metastatic colorectal cancer (mCRC) when started with the first or second intravenous 5-FU\u2013based chemotherapy for metastatic cancer; advanced nonsquamous non-small-cell lung cancer (NSCLC) with carboplatin and paclitaxel in people who have not received chemotherapy for their advanced disease; metastatic RCC (mRCC) with interferon alfa; and GBM in adult patients whose cancer has progressed after prior treatment.\u00a0Effectiveness based on tumor response, as no data have shown whether Avastin improves disease-related symptoms or survival in people previously treated for GBM<\/p>\n
Approval conditionally granted in 2008 and withdrawn November 2011 for HER2- metastatic breast cancer (mBC) with Paclitaxel<\/p>\n<\/div>\n
\u00a0![\"\"](\"http:\/\/www.medkoo.com\/Anticancer-trials\/structures\/BKM-120.gif\")
<\/strong><\/h3>\n\nBuparlisib (BKM120)<\/h3>\n
Sponsor:<\/strong>\u00a0Novartis<\/p>\nMethod of Action:<\/strong>\u00a0Pan-PI3K inhibitor<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0mBC (Phase III and confirmatory Phase I\/II); with Fulvestrant, in postmenopausal women with hormone receptor-positive HER2- locally advanced or mBC which progressed on or after aromatase inhibitor (AI) treatment (Phase III; BELLE-2 study recruiting as of November 2012); with Fulvestrant, in postmenopausal women with hormone receptor-positive HER2- AI-treated, locally-advanced or mBC who progressed on or after mTOR inhibitor-based treatment (Phase III; BELLE-3 study, recruiting as of October 2012); with Paclitaxel in patients with HER2- inoperable locally advanced or mBC, with or without PI3K pathway activation (Phase III; BELLE-4 study, recruiting as of November); metastatic castration-resistant prostate cancer (CRPC; Phase II; recruiting as of October); recurrent glioblastoma (Phase II; recruiting as of November); recurrent\/metastatic head and neck squamous cell carcinoma (Phase II; recruiting as of October); endometrial cancer (Phase I\/II); NSCLC (Phase I\/II); prostate cancer (Phase I\/II); GBM multiforme (Phase I\/II); with Fulvestrant in postmenopausal women with estrogen receptor-positive metastatic breast cancer (Phase I); previously treated advanced colorectal cancer (Phase I)<\/p>\n<\/div>\n\u00a0![\"File:Fulvestrant.svg\"](\"http:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/9\/94\/Fulvestrant.svg\/800px-Fulvestrant.svg.png\")
<\/strong><\/h3>\n\nFaslodex (Fulvestrant Injection)<\/strong><\/h3>\nSponsor:<\/strong>\u00a0AstraZeneca<\/p>\nMethod of Action:<\/strong>\u00a0Estrogen receptor antagonist<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0First line HR+ mBC (Phase III; FALCON study commenced Oct. 29)<\/p>\nApproved for HR+ mBC in women who have experienced menopause and whose breast cancer has worsened after they were treated with antiestrogen medications<\/p>\n<\/div>\n
\u00a0![\"\"](\"http:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/0\/0a\/HerceptinFab.jpg\/300px-HerceptinFab.jpg\")
<\/strong><\/h3>\n\nHerceptin (Trastuzumab; RG597)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/02\/23\/fda-approves-kadcyla-ado-trastuzumab-emtansine-a-new-therapy-for-patients-with-her2-positive-late-stage-metastatic-breast-cancer\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Roche, in partnership with Halozyme<\/p>\nMethod of Action:<\/strong>\u00a0Humanized monoclonal antibody designed to target and block the function of HER2+<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0EU: Early HER2+ breast cancer, subcutaneous formulation (Registration)<\/p>\nApproved for early-stage HER2+ breast cancer that has spread into the lymph nodes, and HER2+ breast cancer that has not spread into the lymph nodes and is estrogen receptor\/progesterone receptor-negative (ER-\/PR-) or have one high-risk feature. High-risk is defined as estrogen receptor\/progesterone receptor-positive (ER+\/PR+) with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3. Can be used with Adriamycin\u00ae (doxorubicin), Cytoxan\u00ae (cyclophosphamide), and either Taxol\u00ae (paclitaxel) or Taxotere\u00ae (docetaxel); or with Taxotere and Paraplatin\u00ae (carboplatin); or alone after treatment with multiple other therapies, including an anthracycline (Adriamycin)-based chemotherapy<\/p>\n
Also approved alone for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease; and with paclitaxel for first-line treatment of HER2+ mBC<\/p>\n
\u00a0![\"\"](\"http:\/\/www.lookchem.com\/300w%5C2010-7%5C9f509760-30ac-4b9c-8d20-7fc99bc46839.png\")
<\/strong><\/h3>\n\nIniparib (Tivolza; BSI-201; SAR240550)<\/strong><\/h3>\nSponsor: Sanofi, through acquisition of original developer BiPar Sciences<\/p>\n
Method of Action: Poly (ADP-ribose) polymerase 1 (PARP1) inhibitor<\/p>\n
Indications\/Phase of Trial: Stage IV squamous NSCLC (Phase III; NME); solid tumors such as sarcoma and breast, uterine, lung, and ovarian cancers (Phase I\/II)<\/p>\n
Phase III trial in breast cancer failed January 2011 by failing to improve survival and progression-free survival (PFS) in breast cancer patients<\/p>\n<\/div>\n<\/div>\n
\u00a0![\"\"](\"http:\/\/www.yaopha.com\/wp-content\/uploads\/2012\/11\/Chemical-Structure-of-Nexavar-Sorafenib-Tosylate-%E5%A4%9A%E5%90%89%E7%BE%8E%E7%B4%A2%E6%8B%89%E9%9D%9E%E5%B0%BC%E5%8C%96%E5%AD%A6%E7%BB%93%E6%9E%84-600x180.jpg\")
<\/strong><\/h3>\n\nNexavar\u00ae (Sorafenib)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/07\/16\/nexavar-sorafenib\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Onyx Pharmaceuticals<\/p>\nMethod of Action:<\/strong>\u00a0Dual-action inhibitor that targets RAF\/MEK\/ERK pathway in tumor cells and tyrosine kinases<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0Liver cancer adjuvant (Phase III; STORM study); kidney cancer adjuvant (Phase III; SORCE\/ASSURE study); thyroid cancer monotherapy (Phase III; DECISION study); breast cancer with capecitabine (Phase III; RESILIENCE study)<\/p>\nApproved for hepatocellular carcinoma (HCC) and RCC<\/p>\n<\/div>\n
\u00a0![\"\"](\"http:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/1\/11\/Pertuzumab-HER2_complex_1S78.png\/237px-Pertuzumab-HER2_complex_1S78.png\")
<\/strong><\/h3>\n\nPerjeta (Pertuzumab; RG1273)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/03\/05\/the-european-medicines-agency-ema-has-approved-roches-perjetatm-pertuzumab-for-patients-with-previously-untreated-her2-positive-metastatic-breast-cancer-mbc\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Roche\/Genentech<\/p>\nMethod of Action:<\/strong>\u00a0HER2\/neu receptor antagonist<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0EU: With Herceptin and docetaxel chemotherapy for previously-untreated HER2+ mBC or locally recurrent, inoperable breast cancer in patients who have not received previous treatment or whose disease has returned after treatment in the early-stage setting (Registration)<\/p>\nU.S.: Approved June 2012 for HER2+ mBC with Herceptin (trastuzumab) and docetaxel, in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease<\/p>\n
Switzerland: Approved August 2012 for HER2+ breast cancer with Herceptin (trastuzumab) and docetaxel in patients with advanced or locally recurring breast cancer that has not previously been treated with chemotherapy<\/p>\n<\/div>\n
\u00a0![\"\"](\"http:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/a\/a4\/Deforolimus.svg\/220px-Deforolimus.svg.png\")
<\/strong><\/h3>\n\nRidaforolimus (MK-8669; AP23573; formerly Deforolimus)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/03\/05\/phase-3-breast-cancer-ridaforolimus-mk-8669-ap23573-formerly-deforolimus-merck-licenseariad-pharmaceuticals\/<\/a><\/p>\nSponsor:\u00a0<\/strong>Merck, under exclusive worldwide license agreement with Ariad Pharmaceuticals<\/p>\nMethod of Action:<\/strong>\u00a0Oral inhibitor of mammalian target of rapamycin inhibitor (mTOR)<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0Maintenance therapy for metastatic soft-tissue sarcoma and bone sarcomas after at least four chemotherapy cycles (under review after receiving Complete Response letter from FDA in June; NME); breast cancer with exemestane, compared to breast cancer with dalotuzumab and exemestane (Phase II; recruiting as of November); advanced head and neck cancer, NSCLC and colon cancer, with cetuximab (Phase II); pediatric patients with advanced solid tumors (Phase I; recruiting as of September); with dalotuzumab in pediatric patients with advanced solid tumors (Phase I; recruiting as of August); advanced RCC, with vorinostat (Phase I; recruiting as of October 2012); breast cancer, with dalotuzumab (Phase I: recruiting as of September); endometrial and ovarian cancers, with paclitaxel and carboplatin (Phase I; recruiting as of September 2012); advanced cancer, with MK-2206 and MK-0752 (Phase I: recruiting as of September 2012); advanced cancer, with dalotuzumab, MK-2206 and MK-0752 (Phase I: recruiting as of August 2012)<\/p>\n\u00a0![\"\"](\"https:\/\/encrypted-tbn0.gstatic.com\/images?q=tbn:ANd9GcRTjmmp6-w44p4zG11qj9n4a35v5LZh2_ZAVyguND6M7vIUtue_\")
<\/strong><\/h3>\n\nTivozanib (ASP4130; AV-951)<\/strong><\/h3>\nSponsor:<\/strong>\u00a0Aveo Oncology and Astellas<\/p>\nMethod of Action:<\/strong>\u00a0Tyrosine kinase inhibitor; inhibits VEGF receptor 1, 2, and 3<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0U.S.: Advanced RCC (Registration; NDA filed September 2012); tivozanib biomarkers in solid tumors (Phase II; BATON study); stage IV metastatic colorectal cancer (mCRC), with mFOLFOX6, and compared with bevacizumab and mFOLFOX6 (Phase II; recruiting as of November); additional data as first-line therapy for advanced RCC, followed by sunitinib (Phase II; TAURUS study, enrollment initiated in October 2012); advanced solid tumors, with capecitabine (Xeloda\u00ae; Phase I; recruiting as of October)<\/p>\nEU: Advanced RCC (Phase III)<\/p>\n<\/div>\n<\/div>\n
\u00a0<\/strong><\/h3>\n\nTrastuzumab-DM1 (T-DM1; Trastuzumab emtansine; RG3502)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/02\/23\/fda-approves-kadcyla-ado-trastuzumab-emtansine-a-new-therapy-for-patients-with-her2-positive-late-stage-metastatic-breast-cancer\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Roche, with linker technology developed by ImmunoGen<\/p>\nMethod of Action:<\/strong>\u00a0Antibody-drug conjugate, consisting of the antibody trastuzumab and the chemotherapy DM1 attached via a stable linker<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0U.S.: HER2+, unresectable locally-advanced or mBC who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy (Registration; Priority review approved Nov. 7; action date Feb. 26, 2013)<\/p>\nEU: Marketing Authorization Application for HER2+ mBC accepted for review by European Medicines Agency<\/p>\n<\/div>\n
\u00a0![\"File:Lapatinib.svg\"](\"http:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/1\/1a\/Lapatinib.svg\/800px-Lapatinib.svg.png\")
<\/strong><\/h3>\n\nTyverb\/Tykerb (lapatinib)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/06\/17\/patent-of-fresenius-kabi-oncology-ltd-novel-intermediates-and-process-for-the-preparation-of-lapatinib-and\/<\/a><\/p>\nSponsor:<\/strong>\u00a0GlaxoSmithKline<\/p>\nMethod of Action:<\/strong>\u00a0Human epidermal growth factor receptor-2 (Her2) and epidermal growth factor receptor (EGFR) dual kinase inhibitor<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0mBC with trastuzumab (Registration); breast cancer, adjuvant therapy (Phase III); Gastric cancer (Phase III); head & neck squamous cell carcinoma, resectable disease (Phase III)<\/p>\n<\/div>\n\u00a0<\/strong><\/h3>\n\nXgeva (denosumab)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/06\/14\/fda-approves-xgevadenosumab-to-treat-giant-cell-tumor-of-the-bone\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Amgen, with commercialization by GlaxoSmithKline in countries where Amgen has no presence<\/p>\nMethod of Action:<\/strong>\u00a0Fully human monoclonal antibody that specifically targets a ligand known as RANKL that binds to a receptor known as RANK<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0Delay or prevention of bone metastases in breast cancer (Phase III); delay or prevention of bone metastases in prostate cancer (Phase III)<\/p>\nApproved for prevention of fractures in men with advanced prostate cancer<\/p>\n
Rejected in April for supplemental Biologics License Application to treat men with CRPC at high risk of developing bone metastases<\/p>\n<\/div>\n
\u00a0![\"\"](\"http:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/0\/0c\/Trabectedin.png\/220px-Trabectedin.png\")
<\/strong><\/h3>\n\nYondelis\u00ae (trabectedin)<\/strong><\/h3>\nSponsor:<\/strong>\u00a0Johnson & Johnson; developed in collaboration with PharmaMar<\/p>\nMethod of Action:<\/strong>\u00a0Binds to minor groove of DNA, interfering with the cell division and gene transcription processes, as well as DNA\u2019s repair machinery<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0U.S.: Locally advanced or metastatic soft tissue sarcoma excluding leiomyosarcoma and liposarcoma who have relapsed or are refractory to standard-of-care treatment (Phase III; recruiting as of November); soft tissue sarcoma, excluding liposarcoma and leiomyosarcoma (L-type sarcoma), in previously-treated patients who cannot be expected to benefit from currently available therapeutic options (Phase III; recruiting as of November); locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated with at least an anthracycline and ifosfamide-containing regimen, or an anthracycline-containing regimen and one additional cytotoxic chemotherapy regimen, compared with dacarbazine group (Phase III; recruiting as of November); breast cancer and pediatric tumors (Phase II); Advanced malignancies and liver dysfunction (Phase I; recruiting as of November)<\/p>\nEU: Approved for advanced or metastatic soft tissue sarcoma, and for relapsed platinum-sensitive ovarian cancer, with DOXIL\u00ae\/Caelyx\u00ae<\/p>\n<\/div>\n
\u00a0![\"\"](\"http:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/a\/ae\/Enzalutamide-01.svg\/250px-Enzalutamide-01.svg.png\")
<\/strong><\/h3>\n\nXtandi\u00ae Capsules (Enzalutamide; formerly MDV3100)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/05\/28\/astellas-pharma-and-medivation-have-announced-the-submission-of-application-for-marketing-approval-of-enzalutamide-in-japan-for-the-treatment-of-prostate-cancer\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Medivation in collaboration with Astellas<\/p>\nMethod of Action:<\/strong>\u00a0Androgen receptor inhibitor<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0Prechemotherapy CRPC in patients who have failed luteinizing hormone-releasing hormone (LHRH) analog treatment only, as well as patients who have failed both LHRH analog and anti-androgen treatment. (Phase III; PREVAIL study); prostate cancer neoadjuvant therapy (Phase II); prechemo metastatic prostate cancer in Europe (Phase II; TERRAIN); prechemo metastatic and nonmetastatic prostate cancer patients in U.S. (Phase II; STRIVE); prostate cancer Hormone-na\u00efve (Phase II; ASPIRE); prostate cancer with docetaxel (Phase I); breast cancer (Phase I)<\/p>\nEU: Marketing Authorization Application submitted June 2012 to European Medicines Agency, for patients with metastatic CRPC who have received docetaxel-based chemotherapy<\/p>\n
Japan: Metastatic CRPC who have received docetaxel-based chemotherapy (Phase II)<\/p>\n
Approved Aug. 31 for patients with metastatic CRPC who have previously received docetaxel. As a post-marketing requirement, Medivation and Astellas agreed to conduct an open-label safety study of Xtandi (160 mg\/day) in patients at high risk for seizure, with data to be submitted to FDA in 2019<\/p>\n<\/div>\n<\/div>\n<\/div>\n
![\"Links\"](\"http:\/\/lem.ch.unito.it\/didattica\/infochimica\/Liquidi%20Ionici\/LiquidiIonici_File\/links1.gif\")
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\u00a0 The article is 2012-2013 based and reader discretion is sought to ascertian the stage of approval Breast Cancer Drugs in Late-Stage Development\/Recently\u00a0Approved Afinitor\u00ae (everolimus) http:\/\/newdrugapprovals.wordpress.com\/2013\/04\/27\/drug-spotlight-afinitor-everolimus-novartis\/ Sponsor:\u00a0Novartis Method of Action:\u00a0Mammalian target of rapamycin (mTOR) inhibitor Indications\/Phase of Trial:\u00a0Hepatocellular carcinoma; human epidermal growth factor receptor 2-positive (HER2+) breast cancer first-line and second-line; lymphoma; nonfunctional carcinoid… Continue reading Breast Cancer Drugs in Late-Stage Development\/Recently Approved<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[114,146],"_links":{"self":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts\/1264"}],"collection":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/comments?post=1264"}],"version-history":[{"count":1,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts\/1264\/revisions"}],"predecessor-version":[{"id":1265,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts\/1264\/revisions\/1265"}],"wp:attachment":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/media?parent=1264"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/categories?post=1264"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/tags?post=1264"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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Afinitor\u00ae (everolimus)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/04\/27\/drug-spotlight-afinitor-everolimus-novartis\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Novartis<\/p>\nMethod of Action:<\/strong>\u00a0Mammalian target of rapamycin (mTOR) inhibitor<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0Hepatocellular carcinoma; human epidermal growth factor receptor 2-positive (HER2+) breast cancer first-line and second-line; lymphoma; nonfunctional carcinoid tumor (Phase III; all new indications)<\/p>\nApproved in July in U.S., EU for advanced hormone-receptor-positive (HR+) and human epidermal growth factor Receptor 2-negative (HER2-) metastatic breast cancer with exemestane in postmenopausal women who have already received certain other medicines for their cancer<\/p>\n
Approved earlier for adults with pancreatic neuroendocrine tumors (PNET) that cannot be treated with surgery; adults with advanced renal cell carcinoma (RCC) when certain other medicines have not worked; adults with angiomyolipoma, seen with tuberous sclerosis complex (TSC), when surgery is not required immediately; and adults and children with TSC who have a brain tumor called subependymal giant cell astrocytoma (SEGA) that cannot be removed completely by surgery<\/p>\n<\/div>\n
\u00a0<\/strong><\/h3>\n\nAvastin (Bevacizumab; RG435)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/02\/23\/fda-has-approved-a-new-use-of-avastin-bevacizumab-in-combination-with-fluoropyrimidine-based-irinotecan-or-oxaliplatin-chemotherapy-for-people-with-metastatic-colorectal-cancer-mcrc\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Roche\/Genentech<\/p>\nMethod of Action:<\/strong>\u00a0Monoclonal antibody; Vascular endothelial growth factor (VEGF) inhibitor<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0U.S.: Relapsed ovarian cancer, platinum-sensitive (Registration); first-line metastatic breast cancer and first-line metastatic ovarian cancer (both Phase III).<\/p>\nEU: Relapsed platinum-resistance ovarian cancer (Phase III)<\/p>\n
Metastatic colorectal cancer, treatment beyond progression (Registration); adjuvant breast cancer, HER2- and HER2+; adjuvant NSCLC; first-line glioblastoma (GBM) multiforme; high-risk carcinoid (all Phase III)<\/p>\n
Approved for metastatic colorectal cancer (mCRC) when started with the first or second intravenous 5-FU\u2013based chemotherapy for metastatic cancer; advanced nonsquamous non-small-cell lung cancer (NSCLC) with carboplatin and paclitaxel in people who have not received chemotherapy for their advanced disease; metastatic RCC (mRCC) with interferon alfa; and GBM in adult patients whose cancer has progressed after prior treatment.\u00a0Effectiveness based on tumor response, as no data have shown whether Avastin improves disease-related symptoms or survival in people previously treated for GBM<\/p>\n
Approval conditionally granted in 2008 and withdrawn November 2011 for HER2- metastatic breast cancer (mBC) with Paclitaxel<\/p>\n<\/div>\n
\u00a0<\/strong><\/h3>\n\nBuparlisib (BKM120)<\/h3>\n
Sponsor:<\/strong>\u00a0Novartis<\/p>\nMethod of Action:<\/strong>\u00a0Pan-PI3K inhibitor<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0mBC (Phase III and confirmatory Phase I\/II); with Fulvestrant, in postmenopausal women with hormone receptor-positive HER2- locally advanced or mBC which progressed on or after aromatase inhibitor (AI) treatment (Phase III; BELLE-2 study recruiting as of November 2012); with Fulvestrant, in postmenopausal women with hormone receptor-positive HER2- AI-treated, locally-advanced or mBC who progressed on or after mTOR inhibitor-based treatment (Phase III; BELLE-3 study, recruiting as of October 2012); with Paclitaxel in patients with HER2- inoperable locally advanced or mBC, with or without PI3K pathway activation (Phase III; BELLE-4 study, recruiting as of November); metastatic castration-resistant prostate cancer (CRPC; Phase II; recruiting as of October); recurrent glioblastoma (Phase II; recruiting as of November); recurrent\/metastatic head and neck squamous cell carcinoma (Phase II; recruiting as of October); endometrial cancer (Phase I\/II); NSCLC (Phase I\/II); prostate cancer (Phase I\/II); GBM multiforme (Phase I\/II); with Fulvestrant in postmenopausal women with estrogen receptor-positive metastatic breast cancer (Phase I); previously treated advanced colorectal cancer (Phase I)<\/p>\n<\/div>\n\u00a0<\/strong><\/h3>\n\nFaslodex (Fulvestrant Injection)<\/strong><\/h3>\nSponsor:<\/strong>\u00a0AstraZeneca<\/p>\nMethod of Action:<\/strong>\u00a0Estrogen receptor antagonist<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0First line HR+ mBC (Phase III; FALCON study commenced Oct. 29)<\/p>\nApproved for HR+ mBC in women who have experienced menopause and whose breast cancer has worsened after they were treated with antiestrogen medications<\/p>\n<\/div>\n
\u00a0<\/strong><\/h3>\n\nHerceptin (Trastuzumab; RG597)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/02\/23\/fda-approves-kadcyla-ado-trastuzumab-emtansine-a-new-therapy-for-patients-with-her2-positive-late-stage-metastatic-breast-cancer\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Roche, in partnership with Halozyme<\/p>\nMethod of Action:<\/strong>\u00a0Humanized monoclonal antibody designed to target and block the function of HER2+<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0EU: Early HER2+ breast cancer, subcutaneous formulation (Registration)<\/p>\nApproved for early-stage HER2+ breast cancer that has spread into the lymph nodes, and HER2+ breast cancer that has not spread into the lymph nodes and is estrogen receptor\/progesterone receptor-negative (ER-\/PR-) or have one high-risk feature. High-risk is defined as estrogen receptor\/progesterone receptor-positive (ER+\/PR+) with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3. Can be used with Adriamycin\u00ae (doxorubicin), Cytoxan\u00ae (cyclophosphamide), and either Taxol\u00ae (paclitaxel) or Taxotere\u00ae (docetaxel); or with Taxotere and Paraplatin\u00ae (carboplatin); or alone after treatment with multiple other therapies, including an anthracycline (Adriamycin)-based chemotherapy<\/p>\n
Also approved alone for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease; and with paclitaxel for first-line treatment of HER2+ mBC<\/p>\n
\u00a0<\/strong><\/h3>\n\nIniparib (Tivolza; BSI-201; SAR240550)<\/strong><\/h3>\nSponsor: Sanofi, through acquisition of original developer BiPar Sciences<\/p>\n
Method of Action: Poly (ADP-ribose) polymerase 1 (PARP1) inhibitor<\/p>\n
Indications\/Phase of Trial: Stage IV squamous NSCLC (Phase III; NME); solid tumors such as sarcoma and breast, uterine, lung, and ovarian cancers (Phase I\/II)<\/p>\n
Phase III trial in breast cancer failed January 2011 by failing to improve survival and progression-free survival (PFS) in breast cancer patients<\/p>\n<\/div>\n<\/div>\n
\u00a0<\/strong><\/h3>\n\nNexavar\u00ae (Sorafenib)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/07\/16\/nexavar-sorafenib\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Onyx Pharmaceuticals<\/p>\nMethod of Action:<\/strong>\u00a0Dual-action inhibitor that targets RAF\/MEK\/ERK pathway in tumor cells and tyrosine kinases<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0Liver cancer adjuvant (Phase III; STORM study); kidney cancer adjuvant (Phase III; SORCE\/ASSURE study); thyroid cancer monotherapy (Phase III; DECISION study); breast cancer with capecitabine (Phase III; RESILIENCE study)<\/p>\nApproved for hepatocellular carcinoma (HCC) and RCC<\/p>\n<\/div>\n
\u00a0<\/strong><\/h3>\n\nPerjeta (Pertuzumab; RG1273)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/03\/05\/the-european-medicines-agency-ema-has-approved-roches-perjetatm-pertuzumab-for-patients-with-previously-untreated-her2-positive-metastatic-breast-cancer-mbc\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Roche\/Genentech<\/p>\nMethod of Action:<\/strong>\u00a0HER2\/neu receptor antagonist<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0EU: With Herceptin and docetaxel chemotherapy for previously-untreated HER2+ mBC or locally recurrent, inoperable breast cancer in patients who have not received previous treatment or whose disease has returned after treatment in the early-stage setting (Registration)<\/p>\nU.S.: Approved June 2012 for HER2+ mBC with Herceptin (trastuzumab) and docetaxel, in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease<\/p>\n
Switzerland: Approved August 2012 for HER2+ breast cancer with Herceptin (trastuzumab) and docetaxel in patients with advanced or locally recurring breast cancer that has not previously been treated with chemotherapy<\/p>\n<\/div>\n
\u00a0<\/strong><\/h3>\n\nRidaforolimus (MK-8669; AP23573; formerly Deforolimus)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/03\/05\/phase-3-breast-cancer-ridaforolimus-mk-8669-ap23573-formerly-deforolimus-merck-licenseariad-pharmaceuticals\/<\/a><\/p>\nSponsor:\u00a0<\/strong>Merck, under exclusive worldwide license agreement with Ariad Pharmaceuticals<\/p>\nMethod of Action:<\/strong>\u00a0Oral inhibitor of mammalian target of rapamycin inhibitor (mTOR)<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0Maintenance therapy for metastatic soft-tissue sarcoma and bone sarcomas after at least four chemotherapy cycles (under review after receiving Complete Response letter from FDA in June; NME); breast cancer with exemestane, compared to breast cancer with dalotuzumab and exemestane (Phase II; recruiting as of November); advanced head and neck cancer, NSCLC and colon cancer, with cetuximab (Phase II); pediatric patients with advanced solid tumors (Phase I; recruiting as of September); with dalotuzumab in pediatric patients with advanced solid tumors (Phase I; recruiting as of August); advanced RCC, with vorinostat (Phase I; recruiting as of October 2012); breast cancer, with dalotuzumab (Phase I: recruiting as of September); endometrial and ovarian cancers, with paclitaxel and carboplatin (Phase I; recruiting as of September 2012); advanced cancer, with MK-2206 and MK-0752 (Phase I: recruiting as of September 2012); advanced cancer, with dalotuzumab, MK-2206 and MK-0752 (Phase I: recruiting as of August 2012)<\/p>\n\u00a0<\/strong><\/h3>\n\nTivozanib (ASP4130; AV-951)<\/strong><\/h3>\nSponsor:<\/strong>\u00a0Aveo Oncology and Astellas<\/p>\nMethod of Action:<\/strong>\u00a0Tyrosine kinase inhibitor; inhibits VEGF receptor 1, 2, and 3<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0U.S.: Advanced RCC (Registration; NDA filed September 2012); tivozanib biomarkers in solid tumors (Phase II; BATON study); stage IV metastatic colorectal cancer (mCRC), with mFOLFOX6, and compared with bevacizumab and mFOLFOX6 (Phase II; recruiting as of November); additional data as first-line therapy for advanced RCC, followed by sunitinib (Phase II; TAURUS study, enrollment initiated in October 2012); advanced solid tumors, with capecitabine (Xeloda\u00ae; Phase I; recruiting as of October)<\/p>\nEU: Advanced RCC (Phase III)<\/p>\n<\/div>\n<\/div>\n
\u00a0<\/strong><\/h3>\n\nTrastuzumab-DM1 (T-DM1; Trastuzumab emtansine; RG3502)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/02\/23\/fda-approves-kadcyla-ado-trastuzumab-emtansine-a-new-therapy-for-patients-with-her2-positive-late-stage-metastatic-breast-cancer\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Roche, with linker technology developed by ImmunoGen<\/p>\nMethod of Action:<\/strong>\u00a0Antibody-drug conjugate, consisting of the antibody trastuzumab and the chemotherapy DM1 attached via a stable linker<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0U.S.: HER2+, unresectable locally-advanced or mBC who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy (Registration; Priority review approved Nov. 7; action date Feb. 26, 2013)<\/p>\nEU: Marketing Authorization Application for HER2+ mBC accepted for review by European Medicines Agency<\/p>\n<\/div>\n
\u00a0<\/strong><\/h3>\n\nTyverb\/Tykerb (lapatinib)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/06\/17\/patent-of-fresenius-kabi-oncology-ltd-novel-intermediates-and-process-for-the-preparation-of-lapatinib-and\/<\/a><\/p>\nSponsor:<\/strong>\u00a0GlaxoSmithKline<\/p>\nMethod of Action:<\/strong>\u00a0Human epidermal growth factor receptor-2 (Her2) and epidermal growth factor receptor (EGFR) dual kinase inhibitor<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0mBC with trastuzumab (Registration); breast cancer, adjuvant therapy (Phase III); Gastric cancer (Phase III); head & neck squamous cell carcinoma, resectable disease (Phase III)<\/p>\n<\/div>\n\u00a0<\/strong><\/h3>\n\nXgeva (denosumab)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/06\/14\/fda-approves-xgevadenosumab-to-treat-giant-cell-tumor-of-the-bone\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Amgen, with commercialization by GlaxoSmithKline in countries where Amgen has no presence<\/p>\nMethod of Action:<\/strong>\u00a0Fully human monoclonal antibody that specifically targets a ligand known as RANKL that binds to a receptor known as RANK<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0Delay or prevention of bone metastases in breast cancer (Phase III); delay or prevention of bone metastases in prostate cancer (Phase III)<\/p>\nApproved for prevention of fractures in men with advanced prostate cancer<\/p>\n
Rejected in April for supplemental Biologics License Application to treat men with CRPC at high risk of developing bone metastases<\/p>\n<\/div>\n
\u00a0<\/strong><\/h3>\n\nYondelis\u00ae (trabectedin)<\/strong><\/h3>\nSponsor:<\/strong>\u00a0Johnson & Johnson; developed in collaboration with PharmaMar<\/p>\nMethod of Action:<\/strong>\u00a0Binds to minor groove of DNA, interfering with the cell division and gene transcription processes, as well as DNA\u2019s repair machinery<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0U.S.: Locally advanced or metastatic soft tissue sarcoma excluding leiomyosarcoma and liposarcoma who have relapsed or are refractory to standard-of-care treatment (Phase III; recruiting as of November); soft tissue sarcoma, excluding liposarcoma and leiomyosarcoma (L-type sarcoma), in previously-treated patients who cannot be expected to benefit from currently available therapeutic options (Phase III; recruiting as of November); locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated with at least an anthracycline and ifosfamide-containing regimen, or an anthracycline-containing regimen and one additional cytotoxic chemotherapy regimen, compared with dacarbazine group (Phase III; recruiting as of November); breast cancer and pediatric tumors (Phase II); Advanced malignancies and liver dysfunction (Phase I; recruiting as of November)<\/p>\nEU: Approved for advanced or metastatic soft tissue sarcoma, and for relapsed platinum-sensitive ovarian cancer, with DOXIL\u00ae\/Caelyx\u00ae<\/p>\n<\/div>\n
\u00a0<\/strong><\/h3>\n\nXtandi\u00ae Capsules (Enzalutamide; formerly MDV3100)<\/strong><\/h3>\nhttp:\/\/newdrugapprovals.wordpress.com\/2013\/05\/28\/astellas-pharma-and-medivation-have-announced-the-submission-of-application-for-marketing-approval-of-enzalutamide-in-japan-for-the-treatment-of-prostate-cancer\/<\/a><\/p>\nSponsor:<\/strong>\u00a0Medivation in collaboration with Astellas<\/p>\nMethod of Action:<\/strong>\u00a0Androgen receptor inhibitor<\/p>\nIndications\/Phase of Trial:<\/strong>\u00a0Prechemotherapy CRPC in patients who have failed luteinizing hormone-releasing hormone (LHRH) analog treatment only, as well as patients who have failed both LHRH analog and anti-androgen treatment. (Phase III; PREVAIL study); prostate cancer neoadjuvant therapy (Phase II); prechemo metastatic prostate cancer in Europe (Phase II; TERRAIN); prechemo metastatic and nonmetastatic prostate cancer patients in U.S. (Phase II; STRIVE); prostate cancer Hormone-na\u00efve (Phase II; ASPIRE); prostate cancer with docetaxel (Phase I); breast cancer (Phase I)<\/p>\nEU: Marketing Authorization Application submitted June 2012 to European Medicines Agency, for patients with metastatic CRPC who have received docetaxel-based chemotherapy<\/p>\n
Japan: Metastatic CRPC who have received docetaxel-based chemotherapy (Phase II)<\/p>\n
Approved Aug. 31 for patients with metastatic CRPC who have previously received docetaxel. As a post-marketing requirement, Medivation and Astellas agreed to conduct an open-label safety study of Xtandi (160 mg\/day) in patients at high risk for seizure, with data to be submitted to FDA in 2019<\/p>\n<\/div>\n<\/div>\n<\/div>\n
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\u00a0 The article is 2012-2013 based and reader discretion is sought to ascertian the stage of approval Breast Cancer Drugs in Late-Stage Development\/Recently\u00a0Approved Afinitor\u00ae (everolimus) http:\/\/newdrugapprovals.wordpress.com\/2013\/04\/27\/drug-spotlight-afinitor-everolimus-novartis\/ Sponsor:\u00a0Novartis Method of Action:\u00a0Mammalian target of rapamycin (mTOR) inhibitor Indications\/Phase of Trial:\u00a0Hepatocellular carcinoma; human epidermal growth factor receptor 2-positive (HER2+) breast cancer first-line and second-line; lymphoma; nonfunctional carcinoid… Continue reading Breast Cancer Drugs in Late-Stage Development\/Recently Approved<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[114,146],"_links":{"self":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts\/1264"}],"collection":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/comments?post=1264"}],"version-history":[{"count":1,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts\/1264\/revisions"}],"predecessor-version":[{"id":1265,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts\/1264\/revisions\/1265"}],"wp:attachment":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/media?parent=1264"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/categories?post=1264"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/tags?post=1264"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Sponsor:<\/strong>\u00a0Novartis<\/p>\n Method of Action:<\/strong>\u00a0Mammalian target of rapamycin (mTOR) inhibitor<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0Hepatocellular carcinoma; human epidermal growth factor receptor 2-positive (HER2+) breast cancer first-line and second-line; lymphoma; nonfunctional carcinoid tumor (Phase III; all new indications)<\/p>\n Approved in July in U.S., EU for advanced hormone-receptor-positive (HR+) and human epidermal growth factor Receptor 2-negative (HER2-) metastatic breast cancer with exemestane in postmenopausal women who have already received certain other medicines for their cancer<\/p>\n Approved earlier for adults with pancreatic neuroendocrine tumors (PNET) that cannot be treated with surgery; adults with advanced renal cell carcinoma (RCC) when certain other medicines have not worked; adults with angiomyolipoma, seen with tuberous sclerosis complex (TSC), when surgery is not required immediately; and adults and children with TSC who have a brain tumor called subependymal giant cell astrocytoma (SEGA) that cannot be removed completely by surgery<\/p>\n<\/div>\n http:\/\/newdrugapprovals.wordpress.com\/2013\/02\/23\/fda-has-approved-a-new-use-of-avastin-bevacizumab-in-combination-with-fluoropyrimidine-based-irinotecan-or-oxaliplatin-chemotherapy-for-people-with-metastatic-colorectal-cancer-mcrc\/<\/a><\/p>\n Sponsor:<\/strong>\u00a0Roche\/Genentech<\/p>\n Method of Action:<\/strong>\u00a0Monoclonal antibody; Vascular endothelial growth factor (VEGF) inhibitor<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0U.S.: Relapsed ovarian cancer, platinum-sensitive (Registration); first-line metastatic breast cancer and first-line metastatic ovarian cancer (both Phase III).<\/p>\n EU: Relapsed platinum-resistance ovarian cancer (Phase III)<\/p>\n Metastatic colorectal cancer, treatment beyond progression (Registration); adjuvant breast cancer, HER2- and HER2+; adjuvant NSCLC; first-line glioblastoma (GBM) multiforme; high-risk carcinoid (all Phase III)<\/p>\n Approved for metastatic colorectal cancer (mCRC) when started with the first or second intravenous 5-FU\u2013based chemotherapy for metastatic cancer; advanced nonsquamous non-small-cell lung cancer (NSCLC) with carboplatin and paclitaxel in people who have not received chemotherapy for their advanced disease; metastatic RCC (mRCC) with interferon alfa; and GBM in adult patients whose cancer has progressed after prior treatment.\u00a0Effectiveness based on tumor response, as no data have shown whether Avastin improves disease-related symptoms or survival in people previously treated for GBM<\/p>\n Approval conditionally granted in 2008 and withdrawn November 2011 for HER2- metastatic breast cancer (mBC) with Paclitaxel<\/p>\n<\/div>\n Sponsor:<\/strong>\u00a0Novartis<\/p>\n Method of Action:<\/strong>\u00a0Pan-PI3K inhibitor<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0mBC (Phase III and confirmatory Phase I\/II); with Fulvestrant, in postmenopausal women with hormone receptor-positive HER2- locally advanced or mBC which progressed on or after aromatase inhibitor (AI) treatment (Phase III; BELLE-2 study recruiting as of November 2012); with Fulvestrant, in postmenopausal women with hormone receptor-positive HER2- AI-treated, locally-advanced or mBC who progressed on or after mTOR inhibitor-based treatment (Phase III; BELLE-3 study, recruiting as of October 2012); with Paclitaxel in patients with HER2- inoperable locally advanced or mBC, with or without PI3K pathway activation (Phase III; BELLE-4 study, recruiting as of November); metastatic castration-resistant prostate cancer (CRPC; Phase II; recruiting as of October); recurrent glioblastoma (Phase II; recruiting as of November); recurrent\/metastatic head and neck squamous cell carcinoma (Phase II; recruiting as of October); endometrial cancer (Phase I\/II); NSCLC (Phase I\/II); prostate cancer (Phase I\/II); GBM multiforme (Phase I\/II); with Fulvestrant in postmenopausal women with estrogen receptor-positive metastatic breast cancer (Phase I); previously treated advanced colorectal cancer (Phase I)<\/p>\n<\/div>\n Sponsor:<\/strong>\u00a0AstraZeneca<\/p>\n Method of Action:<\/strong>\u00a0Estrogen receptor antagonist<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0First line HR+ mBC (Phase III; FALCON study commenced Oct. 29)<\/p>\n Approved for HR+ mBC in women who have experienced menopause and whose breast cancer has worsened after they were treated with antiestrogen medications<\/p>\n<\/div>\n http:\/\/newdrugapprovals.wordpress.com\/2013\/02\/23\/fda-approves-kadcyla-ado-trastuzumab-emtansine-a-new-therapy-for-patients-with-her2-positive-late-stage-metastatic-breast-cancer\/<\/a><\/p>\n Sponsor:<\/strong>\u00a0Roche, in partnership with Halozyme<\/p>\n Method of Action:<\/strong>\u00a0Humanized monoclonal antibody designed to target and block the function of HER2+<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0EU: Early HER2+ breast cancer, subcutaneous formulation (Registration)<\/p>\n Approved for early-stage HER2+ breast cancer that has spread into the lymph nodes, and HER2+ breast cancer that has not spread into the lymph nodes and is estrogen receptor\/progesterone receptor-negative (ER-\/PR-) or have one high-risk feature. High-risk is defined as estrogen receptor\/progesterone receptor-positive (ER+\/PR+) with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3. Can be used with Adriamycin\u00ae (doxorubicin), Cytoxan\u00ae (cyclophosphamide), and either Taxol\u00ae (paclitaxel) or Taxotere\u00ae (docetaxel); or with Taxotere and Paraplatin\u00ae (carboplatin); or alone after treatment with multiple other therapies, including an anthracycline (Adriamycin)-based chemotherapy<\/p>\n Also approved alone for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease; and with paclitaxel for first-line treatment of HER2+ mBC<\/p>\n Sponsor: Sanofi, through acquisition of original developer BiPar Sciences<\/p>\n Method of Action: Poly (ADP-ribose) polymerase 1 (PARP1) inhibitor<\/p>\n Indications\/Phase of Trial: Stage IV squamous NSCLC (Phase III; NME); solid tumors such as sarcoma and breast, uterine, lung, and ovarian cancers (Phase I\/II)<\/p>\n Phase III trial in breast cancer failed January 2011 by failing to improve survival and progression-free survival (PFS) in breast cancer patients<\/p>\n<\/div>\n<\/div>\n http:\/\/newdrugapprovals.wordpress.com\/2013\/07\/16\/nexavar-sorafenib\/<\/a><\/p>\n Sponsor:<\/strong>\u00a0Onyx Pharmaceuticals<\/p>\n Method of Action:<\/strong>\u00a0Dual-action inhibitor that targets RAF\/MEK\/ERK pathway in tumor cells and tyrosine kinases<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0Liver cancer adjuvant (Phase III; STORM study); kidney cancer adjuvant (Phase III; SORCE\/ASSURE study); thyroid cancer monotherapy (Phase III; DECISION study); breast cancer with capecitabine (Phase III; RESILIENCE study)<\/p>\n Approved for hepatocellular carcinoma (HCC) and RCC<\/p>\n<\/div>\n http:\/\/newdrugapprovals.wordpress.com\/2013\/03\/05\/the-european-medicines-agency-ema-has-approved-roches-perjetatm-pertuzumab-for-patients-with-previously-untreated-her2-positive-metastatic-breast-cancer-mbc\/<\/a><\/p>\n Sponsor:<\/strong>\u00a0Roche\/Genentech<\/p>\n Method of Action:<\/strong>\u00a0HER2\/neu receptor antagonist<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0EU: With Herceptin and docetaxel chemotherapy for previously-untreated HER2+ mBC or locally recurrent, inoperable breast cancer in patients who have not received previous treatment or whose disease has returned after treatment in the early-stage setting (Registration)<\/p>\n U.S.: Approved June 2012 for HER2+ mBC with Herceptin (trastuzumab) and docetaxel, in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease<\/p>\n Switzerland: Approved August 2012 for HER2+ breast cancer with Herceptin (trastuzumab) and docetaxel in patients with advanced or locally recurring breast cancer that has not previously been treated with chemotherapy<\/p>\n<\/div>\n http:\/\/newdrugapprovals.wordpress.com\/2013\/03\/05\/phase-3-breast-cancer-ridaforolimus-mk-8669-ap23573-formerly-deforolimus-merck-licenseariad-pharmaceuticals\/<\/a><\/p>\n Sponsor:\u00a0<\/strong>Merck, under exclusive worldwide license agreement with Ariad Pharmaceuticals<\/p>\n Method of Action:<\/strong>\u00a0Oral inhibitor of mammalian target of rapamycin inhibitor (mTOR)<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0Maintenance therapy for metastatic soft-tissue sarcoma and bone sarcomas after at least four chemotherapy cycles (under review after receiving Complete Response letter from FDA in June; NME); breast cancer with exemestane, compared to breast cancer with dalotuzumab and exemestane (Phase II; recruiting as of November); advanced head and neck cancer, NSCLC and colon cancer, with cetuximab (Phase II); pediatric patients with advanced solid tumors (Phase I; recruiting as of September); with dalotuzumab in pediatric patients with advanced solid tumors (Phase I; recruiting as of August); advanced RCC, with vorinostat (Phase I; recruiting as of October 2012); breast cancer, with dalotuzumab (Phase I: recruiting as of September); endometrial and ovarian cancers, with paclitaxel and carboplatin (Phase I; recruiting as of September 2012); advanced cancer, with MK-2206 and MK-0752 (Phase I: recruiting as of September 2012); advanced cancer, with dalotuzumab, MK-2206 and MK-0752 (Phase I: recruiting as of August 2012)<\/p>\n Sponsor:<\/strong>\u00a0Aveo Oncology and Astellas<\/p>\n Method of Action:<\/strong>\u00a0Tyrosine kinase inhibitor; inhibits VEGF receptor 1, 2, and 3<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0U.S.: Advanced RCC (Registration; NDA filed September 2012); tivozanib biomarkers in solid tumors (Phase II; BATON study); stage IV metastatic colorectal cancer (mCRC), with mFOLFOX6, and compared with bevacizumab and mFOLFOX6 (Phase II; recruiting as of November); additional data as first-line therapy for advanced RCC, followed by sunitinib (Phase II; TAURUS study, enrollment initiated in October 2012); advanced solid tumors, with capecitabine (Xeloda\u00ae; Phase I; recruiting as of October)<\/p>\n EU: Advanced RCC (Phase III)<\/p>\n<\/div>\n<\/div>\n http:\/\/newdrugapprovals.wordpress.com\/2013\/02\/23\/fda-approves-kadcyla-ado-trastuzumab-emtansine-a-new-therapy-for-patients-with-her2-positive-late-stage-metastatic-breast-cancer\/<\/a><\/p>\n Sponsor:<\/strong>\u00a0Roche, with linker technology developed by ImmunoGen<\/p>\n Method of Action:<\/strong>\u00a0Antibody-drug conjugate, consisting of the antibody trastuzumab and the chemotherapy DM1 attached via a stable linker<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0U.S.: HER2+, unresectable locally-advanced or mBC who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy (Registration; Priority review approved Nov. 7; action date Feb. 26, 2013)<\/p>\n EU: Marketing Authorization Application for HER2+ mBC accepted for review by European Medicines Agency<\/p>\n<\/div>\n http:\/\/newdrugapprovals.wordpress.com\/2013\/06\/17\/patent-of-fresenius-kabi-oncology-ltd-novel-intermediates-and-process-for-the-preparation-of-lapatinib-and\/<\/a><\/p>\n Sponsor:<\/strong>\u00a0GlaxoSmithKline<\/p>\n Method of Action:<\/strong>\u00a0Human epidermal growth factor receptor-2 (Her2) and epidermal growth factor receptor (EGFR) dual kinase inhibitor<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0mBC with trastuzumab (Registration); breast cancer, adjuvant therapy (Phase III); Gastric cancer (Phase III); head & neck squamous cell carcinoma, resectable disease (Phase III)<\/p>\n<\/div>\n http:\/\/newdrugapprovals.wordpress.com\/2013\/06\/14\/fda-approves-xgevadenosumab-to-treat-giant-cell-tumor-of-the-bone\/<\/a><\/p>\n Sponsor:<\/strong>\u00a0Amgen, with commercialization by GlaxoSmithKline in countries where Amgen has no presence<\/p>\n Method of Action:<\/strong>\u00a0Fully human monoclonal antibody that specifically targets a ligand known as RANKL that binds to a receptor known as RANK<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0Delay or prevention of bone metastases in breast cancer (Phase III); delay or prevention of bone metastases in prostate cancer (Phase III)<\/p>\n Approved for prevention of fractures in men with advanced prostate cancer<\/p>\n Rejected in April for supplemental Biologics License Application to treat men with CRPC at high risk of developing bone metastases<\/p>\n<\/div>\n Sponsor:<\/strong>\u00a0Johnson & Johnson; developed in collaboration with PharmaMar<\/p>\n Method of Action:<\/strong>\u00a0Binds to minor groove of DNA, interfering with the cell division and gene transcription processes, as well as DNA\u2019s repair machinery<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0U.S.: Locally advanced or metastatic soft tissue sarcoma excluding leiomyosarcoma and liposarcoma who have relapsed or are refractory to standard-of-care treatment (Phase III; recruiting as of November); soft tissue sarcoma, excluding liposarcoma and leiomyosarcoma (L-type sarcoma), in previously-treated patients who cannot be expected to benefit from currently available therapeutic options (Phase III; recruiting as of November); locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated with at least an anthracycline and ifosfamide-containing regimen, or an anthracycline-containing regimen and one additional cytotoxic chemotherapy regimen, compared with dacarbazine group (Phase III; recruiting as of November); breast cancer and pediatric tumors (Phase II); Advanced malignancies and liver dysfunction (Phase I; recruiting as of November)<\/p>\n EU: Approved for advanced or metastatic soft tissue sarcoma, and for relapsed platinum-sensitive ovarian cancer, with DOXIL\u00ae\/Caelyx\u00ae<\/p>\n<\/div>\n http:\/\/newdrugapprovals.wordpress.com\/2013\/05\/28\/astellas-pharma-and-medivation-have-announced-the-submission-of-application-for-marketing-approval-of-enzalutamide-in-japan-for-the-treatment-of-prostate-cancer\/<\/a><\/p>\n Sponsor:<\/strong>\u00a0Medivation in collaboration with Astellas<\/p>\n Method of Action:<\/strong>\u00a0Androgen receptor inhibitor<\/p>\n Indications\/Phase of Trial:<\/strong>\u00a0Prechemotherapy CRPC in patients who have failed luteinizing hormone-releasing hormone (LHRH) analog treatment only, as well as patients who have failed both LHRH analog and anti-androgen treatment. (Phase III; PREVAIL study); prostate cancer neoadjuvant therapy (Phase II); prechemo metastatic prostate cancer in Europe (Phase II; TERRAIN); prechemo metastatic and nonmetastatic prostate cancer patients in U.S. (Phase II; STRIVE); prostate cancer Hormone-na\u00efve (Phase II; ASPIRE); prostate cancer with docetaxel (Phase I); breast cancer (Phase I)<\/p>\n EU: Marketing Authorization Application submitted June 2012 to European Medicines Agency, for patients with metastatic CRPC who have received docetaxel-based chemotherapy<\/p>\n Japan: Metastatic CRPC who have received docetaxel-based chemotherapy (Phase II)<\/p>\n Approved Aug. 31 for patients with metastatic CRPC who have previously received docetaxel. As a post-marketing requirement, Medivation and Astellas agreed to conduct an open-label safety study of Xtandi (160 mg\/day) in patients at high risk for seizure, with data to be submitted to FDA in 2019<\/p>\n<\/div>\n<\/div>\n<\/div>\n <\/p>\n <\/p>\n \u00a0 The article is 2012-2013 based and reader discretion is sought to ascertian the stage of approval Breast Cancer Drugs in Late-Stage Development\/Recently\u00a0Approved Afinitor\u00ae (everolimus) http:\/\/newdrugapprovals.wordpress.com\/2013\/04\/27\/drug-spotlight-afinitor-everolimus-novartis\/ Sponsor:\u00a0Novartis Method of Action:\u00a0Mammalian target of rapamycin (mTOR) inhibitor Indications\/Phase of Trial:\u00a0Hepatocellular carcinoma; human epidermal growth factor receptor 2-positive (HER2+) breast cancer first-line and second-line; lymphoma; nonfunctional carcinoid… Continue reading Breast Cancer Drugs in Late-Stage Development\/Recently Approved<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[114,146],"_links":{"self":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts\/1264"}],"collection":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/comments?post=1264"}],"version-history":[{"count":1,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts\/1264\/revisions"}],"predecessor-version":[{"id":1265,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/posts\/1264\/revisions\/1265"}],"wp:attachment":[{"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/media?parent=1264"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/categories?post=1264"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/amcrasto.theeurekamoments.com\/wp-json\/wp\/v2\/tags?post=1264"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\u00a0
<\/strong><\/h3>\n
Avastin (Bevacizumab; RG435)<\/strong><\/h3>\n
\u00a0
<\/strong><\/h3>\nBuparlisib (BKM120)<\/h3>\n
\u00a0
<\/strong><\/h3>\nFaslodex (Fulvestrant Injection)<\/strong><\/h3>\n
\u00a0
<\/strong><\/h3>\nHerceptin (Trastuzumab; RG597)<\/strong><\/h3>\n
\u00a0
<\/strong><\/h3>\nIniparib (Tivolza; BSI-201; SAR240550)<\/strong><\/h3>\n
\u00a0
<\/strong><\/h3>\nNexavar\u00ae (Sorafenib)<\/strong><\/h3>\n
\u00a0
<\/strong><\/h3>\nPerjeta (Pertuzumab; RG1273)<\/strong><\/h3>\n
\u00a0
<\/strong><\/h3>\nRidaforolimus (MK-8669; AP23573; formerly Deforolimus)<\/strong><\/h3>\n
\u00a0
<\/strong><\/h3>\n
Tivozanib (ASP4130; AV-951)<\/strong><\/h3>\n
\u00a0<\/strong><\/h3>\n
Trastuzumab-DM1 (T-DM1; Trastuzumab emtansine; RG3502)<\/strong><\/h3>\n
\u00a0
<\/strong><\/h3>\nTyverb\/Tykerb (lapatinib)<\/strong><\/h3>\n
\u00a0<\/strong><\/h3>\n
Xgeva (denosumab)<\/strong><\/h3>\n
\u00a0
<\/strong><\/h3>\nYondelis\u00ae (trabectedin)<\/strong><\/h3>\n
\u00a0
<\/strong><\/h3>\nXtandi\u00ae Capsules (Enzalutamide; formerly MDV3100)<\/strong><\/h3>\n
<\/p>\n<\/p>\n","protected":false},"excerpt":{"rendered":"