CHMP recommends Taxotere SCCHN approval expansion

French drug major Sanofi-Aventis says that its anticancer agent Taxotere (docetaxel) has received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP), recommending clearance for its use in patients with head and neck cancer. Specifically, the CHMP has advised that the drug be approved, in combination with cisplatin and 5'-fluorouracil, as an induction therapy for those suffering from locally-advanced squamous cell carcinoma of the head and neck.

After considering data from the Phase III TAX324 trial, in which treated patients achieved survival of 71 months versus just 30 months in the control group, the CHMP issued its guidance that the product's list of indications be extended. At present, the drug is cleared in the USA and Europe as a therapy for cancers of the lung, prostate, stomach and breast. It is also indicated, in combination with cisplatin and fluorouracil, for patients with inoperable locally-advanced SCCHN.

The firm said that a final approval decision for Taxotere's use in the proposed regimen is expected before the end of the year, and added that the US Food and Drug Administration granted similar clearance earlier this year.