Last week The Food and Drug Administration (FDA) approved Taxotere (docetaxel) for the use in combination with cisplatin and fluorouracil prior to radiation therapy for the treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck.
A trial was conducted that included 358 patients with previously untreated, inoperable, locally advanced head and neck cancer. The patients were divided into two groups. One group received Taxotere in combination with cisplatin and fluorouracil and the other group received only cisplatin and fluorouracil. Chemotherapy was administered before radiation treatments. The patients that received the Taxotere experienced a longer survival time and a longer time to disease progression.
Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research said "Today's approval will provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patient's survival."
