FDA Approves Taxotere For Broadened Use In Breast Cancer

Contacts:
Doug Arbesfeld; 610-454-5889; douglas.arbesfeld@rp-rorer.com
Terri Pedone; 610-454-8284; terri.pedone@rp-rorer.com

FDA APPROVES TAXOTERE FOR BROADENED USE IN BREAST CANCER TREATMENT

Breast Cancer Drug Now Available for First-Line Treatment of Metastatic Disease Following Adjuvant Therapy

Collegeville, Pa. -- June 23, 1998 -- More women with locally advanced or metastatic (spreading) breast cancer whose disease has failed a previous chemotherapy now have the option of treatment with Taxotere(r) (docetaxel) for Injection Concentrate, according to a full and expanded approval given the product today by the U.S. Food and Drug Administration (FDA). Taxotere is now available for first-line treatment of metastatic breast cancer in patients whose disease has recurred despite adjuvant therapy. It was developed and is manufactured by Rhone-Poulenc Rorer Inc. (RPR), a global pharmaceutical subsidiary of Rhone-Poulenc S.A. (NYSE: RP).

"We are pleased that this expanded approval will enable more women with metastatic breast cancer to be treated with Taxotere," said Dr. Gary T. Shearman, deputy head of Research and Development and senior vice president, Pharmaceutical Drug Development at RPR. "This represents a significant advance in the treatment of this serious disease."

Taxotere is the first agent in the class of chemotherapeutics known as taxoids to be approved for the treatment of patients with locally advanced or metastatic breast cancer after failure of any prior chemotherapy. Taxotere was previously limited to the treatment of patients resistant to anthracycline-based therapy. Anthracyclines are commonly-used chemotherapeutic agents in the treatment of breast cancer.

"Breast cancer continues to affect the lives of many women," said Susan Nathanson, Ph.D., executive director of Y-ME National Breast Cancer Organization. "These women need options available to them, and with the FDA's approval of powerful drugs, women will continue to have hope in their fight against breast cancer."

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 United States reported 180,000 new cases and nearly 45,000 deaths were attributed to this disease.

Taxotere is the first anticancer agent to show a superior response rate to doxorubicin, a widely-used chemotherapy in the first-line treatment of metastatic breast cancer. It is also the first single agent to demonstrate increased survival among patients with advanced breast cancer when compared to combination chemotherapy.

The FDA decision was based on the clinical results of two large pivotal multicenter Phase III studies involving patients with advanced breast cancer whose disease either relapsed or progressed after treatment with an anthracycline or with an alkylating agent containing regimen.

One randomized Phase III multicenter trial compared Taxotere as a single agent to mitomycin C in combination with vinblastine in patients with metastatic breast cancer that 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 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. The overall response rate among patients treated with Taxotere was 28 percent compared to 9.5 percent among the mitomycin C plus vinblastine patients.

The second randomized Phase III study presented was a multicenter 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 higher overall response rate compared to patients treated with doxorubicin (45 percent for Taxotere vs. 30 percent for doxorubicin). Among patients with liver metastases, the Taxotere response rate was significantly higher than doxorubicin (54 percent vs. 27 percent). Median survival was 14.7 months for the Taxotere treatment group compared to 14.3 months for the doxorubicin treatment group.

In patients with normal liver function, Taxotere side effects include neutropenia, thrombocytopenia, anemia, fluid retention, hypersensitivity, nausea and diarrhea. A three-day premedication regimen with corticosteroids is recommended in order to prevent or reduce hypersensitivity and fluid retention.

Taxotere's mechanism of action 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 than 85,000 breast cancer patients worldwide have been treated with Taxotere. It also has been studied in clinical trials including more than 10,000 patients worldwide.

RhÙne-Poulenc Rorer is a global pharmaceutical company dedicated to improving human health. RhÙne-Poulenc S.A. is a leading life sciences company, growing through innovations in human, plant and animal health and through its specialty chemicals subsidiary, Rhodia. With sales in 1997 of FF90 billion (US $15 billion), the company employs 68,000 people in 160 countries worldwide. The RPR Internet website is http://www.rp-rorer.com.

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