To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Panel Recommends Broader Use Of Taxotere For Breast Cancer URL: http://www.pslgroup.com/dg/81AEA.htm Doctor's Guide June 2, 1998
COLLEGEVILLE, PA -- June 2, 1998 -- The United States Food and Drug Administration's oncologic drugs advisory committee has recommended approval of Rhone-Poulenc Rorer Inc.'s Taxotere(R) (docetaxel) for Injection Concentrate for expanded use for the treatment of patients with locally advanced or metastatic (spreading) breast cancer after failure of previous chemotherapy. Taxotere received a conditional approval in May 1996 that required the company to complete two Phase III clinical trials in metastatic breast cancer. Taxotere was previously approved for the treatment of patients with locally advanced or metastatic breast cancer which has progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapy. Anthracyclines are commonly used chemotherapy agents in the treatment of breast cancer. The committee recommended that Taxotere be approved for use after failure of previous chemotherapy. According to the World Health Organization, more than six million deaths from cancer were reported globally in 1996 -- breast cancer alone killed 386,000 women. In 1997, the U.S. reported 180,000 new cases and nearly 45,000 deaths were attributed to this disease. One randomised Phase III multicentre trial compared Taxotere as a single agent to mitomycin C in combination with vinblastine in patients with metastatic breast cancer that has failed an anthracycline containing regimen. The one-year survival rate among breast cancer patients treated with Taxotere was 49 percent, compared to 33 percent for those treated with the combination mitomycin C and vinblastine. Therefore, 50 percent more patients treated with Taxotere were alive one year after therapy, compared to those treated with the combination therapy. The 18-month survival rate was 33 percent for Taxotere patients, compared to 21 percent for mitomycin C plus vinblastine patients. Survival at 18 months was nearly 60 percent higher among the Taxotere treated patients. "The increase in overall survival for this study is impressive," said Jean Marc Nabholtz, M.D. chairman, Northern Alberta Breast Cancer Program and senior medical oncologist, Cross Cancer Institute, Edmonton, AB. and lead investigator of the study. "Taxotere as a single agent clearly demonstrated superiority to the combination therapy. This is very good news for patients with metastatic breast cancer whose cancer has progressed during or after anthracycline treatment." The second randomised Phase III study presented was a multicentre trial comparing Taxotere to doxorubicin in patients with metastatic breast cancer whose disease failed an alkylating agent containing regimen. Patients treated with Taxotere showed a 50 percent better overall response rate compared to patients treated with doxorubicin (48 percent for Taxotere versus 33 percent for doxorubicin). Among resistant patients (those with disease that had progressed on previous regimens containing alkylating agents) and those with liver metastases, the response rates were significantly higher than doxorubicin (47 percent versus 24 percent for resistant patients and 54 percent versus 27 percent for patients with liver metastases). "The results of this study would seem to indicate that Taxotere is more active than doxorubicin in patients with advanced breast cancer," said John Crown, M.D., of St. Vincent's Hospital in Dublin, Ireland, and one of the study's lead investigators. "Patients treated with Taxotere experienced an efficacy advantage and equivalent quality of life compared to those treated with doxorubicin." In patients with normal liver function, side effects reported to date include neutropenia, thrombocytopenia, anemia, fluid retention, hypersensitivity, nausea and diarrhea. A premedication regimen with corticosteroids is recommended in order to prevent or reduce hypersensitivity and fluid retention. Taxotere is not appropriate therapy for patients with significant liver impairment. Taxotere has been studied in clinical trials including more than 10,000 patients world-wide. It is the first anticancer agent to show superior response rate and predictable safety profile relative to doxorubicin, a chemotherapy considered to be the most effective agent in the first-line treatment of metastatic breast cancer. Taxotere is also the first single agent to demonstrate increased survival among patients with advanced breast cancer when compared to the combination of mitomycin C plus vinblastine. Taxotere inhibits cancer cell division by freezing the cell's internal skeleton, which is made up of elements called microtubules. Microtubules assemble and disassemble during the cell cycle, but Taxotere promotes assembly and blocks disassembly, thus preventing cancer cells from dividing. This unique action causes cancer cell death. More information on: Taxotere and Rhone-Poulenc Rorer Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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