Advanced Squamous Cell Carcinoma

Taxotere receives U.S. FDA approval for treatment for patients with head and neck cancer

Published in Cancer Law Weekly, November 18th, 2006

Sanofi-aventis announced that following a priority review of a supplemental new drug application (sNDA), the U.S. Food and Drug Administration (FDA) has approved Taxotere (docetaxel) injection concentrate in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck.

This approval follows a positive opinion for the same use granted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) in September of this year.

The FDA based its decision on results from the EORTC 24971/TAX 323 phase 3, open-label,...

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Source: Cancer Law Weekly (2006-11-18)

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