Reviewed under a supplemental new drug application (sNDA) priority designation, Sanofi Aventis (NYSE: SNY, EPA: SAN)' Taxotere® (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil has been approved by the USFDA for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN).
The said approval came following a positive opinion for the same use granted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) last month.
According to Marshall Posner, MD, medical director of the head and neck oncology program at Dana-Farber Cancer Institute in Boston:
Find more details about the approval and clinical data at the press release."Survival rates for advanced head and neck cancer have historically been low. This study has shown that induction therapy with a Taxotere®, cisplatin, fluorouracil (TPF) regimen increases survival.
With this approval, I hope to see TPF become the standard of care for induction therapy for patients with this type of cancer."
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