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Nov 27, 2012

15 Breast Cancer Drugs in the Pipeline Right Now

Which candidates are on their way from the lab to the medicine chests of thousands?

15 Breast Cancer Drugs in the Pipeline Right Now

These drug candidates are either in late stages of development or will soon hit the market as new treatments for breast cancer. [© robert mobley - Fotolia.com]

  • According to the CDC, in 2008, over 200,000 women in the U.S. were diagnosed with breast cancer, and over 40,000 women in the U.S. died from it. What new weapons are drug companies adding to the arsenal against this disease? GEN has already given you the top 10 best-selling drugs of the 21st century; now, we present a list of drug candidates for which breast cancer is at least one proposed or approved indication, and for which one indication has reached Phase III or Registration phases.

    Each entry includes the name of the drug candidate, the sponsor (and where applicable, collaboration partners), method of action, indication, and phase of trial. Some products are still in clinical trial phases for new indications or formulations after winning marketing approval for initial indications; these approvals, where applicable, are listed on the bottom of each entry.

  • Afinitor® (everolimus)

    Sponsor: Novartis

    Method of Action: Mammalian target of rapamycin (mTOR) inhibitor

    Indications/Phase of Trial: Hepatocellular 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)

    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

    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

  • Avastin (Bevacizumab; RG435)

    Sponsor: Roche/Genentech

    Method of Action: Monoclonal antibody; Vascular endothelial growth factor (VEGF) inhibitor

    Indications/Phase of Trial: U.S.: Relapsed ovarian cancer, platinum-sensitive (Registration); first-line metastatic breast cancer and first-line metastatic ovarian cancer (both Phase III).

    EU: Relapsed platinum-resistance ovarian cancer (Phase III)

    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)

    Approved for metastatic colorectal cancer (mCRC) when started with the first or second intravenous 5-FU–based 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. Effectiveness based on tumor response, as no data have shown whether Avastin improves disease-related symptoms or survival in people previously treated for GBM

    Approval conditionally granted in 2008 and withdrawn November 2011 for HER2- metastatic breast cancer (mBC) with Paclitaxel

  • Buparlisib (BKM120)

    Sponsor: Novartis

    Method of Action: Pan-PI3K inhibitor

    Indications/Phase of Trial: mBC (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)

  • Faslodex (Fulvestrant Injection)

    Sponsor: AstraZeneca

    Method of Action: Estrogen receptor antagonist

    Indications/Phase of Trial: First line HR+ mBC (Phase III; FALCON study commenced Oct. 29)

    Approved for HR+ mBC in women who have experienced menopause and whose breast cancer has worsened after they were treated with antiestrogen medications

  • Herceptin (Trastuzumab; RG597)

    Sponsor: Roche, in partnership with Halozyme

    Method of Action: Humanized monoclonal antibody designed to target and block the function of HER2+

    Indications/Phase of Trial: EU: Early HER2+ breast cancer, subcutaneous formulation (Registration)

    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® (doxorubicin), Cytoxan® (cyclophosphamide), and either Taxol® (paclitaxel) or Taxotere® (docetaxel); or with Taxotere and Paraplatin® (carboplatin); or alone after treatment with multiple other therapies, including an anthracycline (Adriamycin)-based chemotherapy

    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

  • Iniparib (Tivolza; BSI-201; SAR240550)

    Sponsor: Sanofi, through acquisition of original developer BiPar Sciences

    Method of Action: Poly (ADP-ribose) polymerase 1 (PARP1) inhibitor

    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)

    Phase III trial in breast cancer failed January 2011 by failing to improve survival and progression-free survival (PFS) in breast cancer patients

  • Nexavar® (Sorafenib)

    Sponsor: Onyx Pharmaceuticals

    Method of Action: Dual-action inhibitor that targets RAF/MEK/ERK pathway in tumor cells and tyrosine kinases

    Indications/Phase of Trial: Liver 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)

    Approved for hepatocellular carcinoma (HCC) and RCC


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