The Food and Drug Administration (FDA) today approved Taxotere (docetaxel) Injection Concentrate for use in combination with cisplatin and fluorouracil prior to radiotherapy for the treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN).
This disease represents approximately 3 percent of all new cancer cases in the United States.
"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 patients' survival," said Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research.
Taxotere was approved on the basis of the results of a multicenter, randomized trial of 358 patients with previously untreated, inoperable, locally advanced SCCHN. The patients were divided into two groups; one received Taxotere in combination with the chemotherapy drugs cisplatin and fluorouracil, and the other received only cisplatin and fluorouracil. Chemotherapy was administered prior to radiation therapy. Surgery was allowed after chemotherapy, either before or after radiation therapy. The patients in the Taxotere arm of the trial experienced a longer survival time (18.6 months versus 14.2 months) and a longer time to disease progression or death (11.4 months versus 8.3 months) than the group on cisplatin and fluorouracil alone.
The most frequent adverse events reported during the trial by the patients on Taxotere were decreases in white and red blood cells, loss of hair, inflammation of the mouth and esophagus, and nausea. Compared to patients in the control arm, patients on Taxotere had greater hair loss, decreases in white blood cells, fever or infection with low white blood cells, fluid retention, diarrhea and neurosensory abnormalities.
Taxotere is manufactured by Sanofi-Aventis, Paris, France.