FDA News

Taxotere Granted FDA Priority Review For Treatment Of Locally Advanced Squamous Cell Carcinoma Of The Head And Neck

(June 28, 2007)-- Sanofi-aventis announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and assigned priority review status to the supplemental new drug application (sNDA) for Taxotere (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil for the induction (neo-adjuvant) therapy of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) prior to chemoradiotherapy and surgery.

The FDA grants Priority Review to products that, if approved, would be a significant improvement compared to marketed products, including non-drug products in the treatment, diagnosis or prevention of a disease.The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the Taxotere sNDA is slated for Fall 2007. Currently, Taxotere in combination with cisplatin and fluorouracil is approved for the induction therapy of inoperable advanced SCCHN.(3) To date, Taxotere has received a total of seven indications in the U.S. If granted, this will be the eighth FDA approval for Taxotere in five different tumor types.

"We are very pleased that FDA has granted priority review to Taxotere as part of a sequential treatment program that also includes chemoradiotherapy and surgery for advanced head and neck cancer," said Dr. Nassir Habboubi, Vice President of U.S. Medical Affairs, Oncology, for sanofi-aventis. "We are hopeful that Taxotere may soon be available for many patients suffering from advanced head and neck cancer. Sanofi-aventis is committed to continuing the development of effective chemotherapeutics and seeking FDA review and approvals of treatments for patients with many types of cancer."

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