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FDA Approves Taxotere (Docetaxel) in Combination With Prednisone for Prostate Cancer Therapy

BRIDGEWATER, NJ -- May 20, 2004 -- Aventis (NYSE: AVE) announced today that the U.S. Food and Drug Administration (FDA) has approved TaxotereŽ (docetaxel) Injection Concentrate for use in combination with prednisone as a treatment for men with androgen-independent (hormone-refractory) metastatic prostate cancer.

The FDA approval is based on the final results of a landmark phase III clinical trial that met its primary endpoint of increasing survival in this patient population. The pivotal study, TAX 327, along with an additional study of Taxotere in this patient population, have been selected for presentation at the Plenary Session at the American Society of Clinical Oncology (ASCO) annual meeting on Monday, June 7, in New Orleans, LA. A regulatory submission for Taxotere in prostate cancer is also pending with the European Agency for the Evaluation of Medicinal Products (EMEA).

"This approval for Taxotere provides evidence that our drug can positively impact the lives of men around the world with this disease. In addition, this latest FDA action makes Taxotere the only drug approved for breast, lung and prostate cancer, three of the most prevalent cancers in the world today," said Frank Douglas, MD, PhD, Executive Vice President of Drug Innovation and Approval and a Member of the Board of Management at Aventis.

About Prostate Cancer

Prostate cancer ranks third worldwide in cancer incidence and sixth in cancer mortality among men. In the United States, more than 230,000 American men will be diagnosed with prostate cancer this year, and more than 29,900 will die of the disease.

Current therapy for advanced prostate cancer is hormonal manipulation (i.e., blockage of androgen hormones like testosterone that would otherwise stimulate the growth of prostate cancer cells). However, the effects of this treatment typically last between 24 and 36 months, at which time patients may become refractory to hormonal therapy and be considered candidates for chemotherapy, such as Taxotere.

About Taxotere

Taxotere, a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Taxotere promotes their assembly and blocks their disassembly, thereby preventing many cancer cells from dividing and resulting in cancer cell death.

Taxotere is currently approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin, who had not received prior chemotherapy. It also is approved for patients with unresectable locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.

Among patients receiving Taxotere the most common severe adverse events were low blood cell count, fatigue, diarrhea, and mouth and throat irritation. The most common non-severe side effects include hair loss, numbness, a tingling and/or burning sensation, rash, nail changes, nausea, vomiting, and muscle pain.

Less common severe or potentially life threatening side effects include fluid retention, infections, and allergic reactions.

Patients 65 years of age or older may experience some side effects more frequently. For more information about Taxotere, visit http://www.taxotere.com or see full prescribing information including boxed WARNINGS. For more information about ongoing clinical trials, please call 1-800-RxTrial or visit http://www.aventisoncology.com.


SOURCE: Aventis

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