The approval marks the tenth indication for Taxotere which is already approved for a number of cancers including breast cancer, non-small cell lung cancer and prostate cancer.
The approval of Taxotere was based on a study that showed the drug had a longer progression free survival of 11.4 months, compared with 8.3 months for patients receiving a standard therapy. Survival rates also improved in patients administered with the Taxotere treatment.
“Survival rate for advance head and neck cancer have historically been low,” said Marshall Posner, medical director of the Head and Neck Oncology program at the Dana-Farber Cancer Institute. “This study has shown that induction therapy with Taxotere regimen increase survival.”
This approval follows positive opinion for the same use granted on September 29, 2006 by the European Medicines Agency.