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Drug Treatment of Metastatic Breast Cancer FDA Approval Overview Patricia Cortazar, MD Drugs approved for Metastatic Breast Cancer Methotrexate 1953 Cyclophosphamide 1959 Thiotepa 1959 Vinblastine 1961 5-Fluorouracil 1962 Doxorubicin 1974 Drugs approved in 2nd-3rd line Metastatic Breast Cancer Paclitaxel 1994 Docetaxel 1996 Trastuzumab 1998 Capecitabine 1998 Capecitabine + Docetaxel 2001 Abraxane 2005 Lapatinib 2006 Ixabepilone 2007 Paclitaxel TAXOL? is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated TAXOL Efficacy ResultsFull Approval Docetaxel TAXOTERE? for Injection indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy DocetaxelAccelerated Approval 1996 3 Phase II studies in total 134 patients Dose 100 mg/m2 q 3 weeks Endpoint: Overall RR 41% (95% CI: 33-49) PMC: Submit data from controlled clinical studies (TAX311, TAX304) TAX304 Efficacy ResultsFull Approval Trastuzumab Herceptin? is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. Herceptin monotherapy Full Approval Capecitabine Xeloda? is indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy may be contraindicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents. Capecitabine monotherapy Accelerated Approval Capecitabine Xeloda? is indicated in combination with Taxotere (docetaxel) for the treatment of patients with lo