• 10/20/2006
  • Rockville, MD
  • Patricia Shehan
  • All Headline News (www.allheadlinenews.com)

On Wednesday, the Food and Drug Administration (FDA) approved a new form of drug treatment for patients who have inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN). The approved drug, Taxotere Injection Concentrate (docetaxel; Sanofi-Aventis, Paris, France), is to be used in combination with chemotherapy drugs (cisplatin and fluorouracil) before radiothermy treatment.

Taxotere was studied in a random trial of 358 patients. One group was given Taxotere in combination with the chemotherapy drugs. The other group received only the chemotherapy drugs. The results comparing the additional use of Taxotere showed a longer survival time (18.6 months versus 14.2 months) and a longer time to progression of disease or death (11.4 months versus 8.3 months) than the group who only received the chemotherapy drugs.

Patients with SCCHN represent approximately 3 percent of all new diagnosed cases of cancer in the U.S.

According to the Director of FDA’s Center for Drug Evaluation and Research, Steven Galson, M.D., “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.”

There were some of the usual adverse side effects experienced when comparing the study patients on Taxotere with those who were not on the drug treatment.