SANOFI-AVENTIS' TAXOTERE APPROVED FOR HEAD AND NECK CANCER

Sanofi-aventis announced that, following a priority review of its supplemental new drug application (sNDA), the FDA has approved Taxotere (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable, locally advanced, squamous-cell carcinoma of the head and neck.

The FDA based its decision on results from the EORTC 24971/TAX 323 Phase III, open-label, randomized study, which enrolled 358 patients with head and neck cancer.

Patients receiving the Taxotere-based regimen (Taxotere, cisplatin and fluorouracil) had a significantly longer progression-free survival of 11.4 months, compared with 8.3 months for the patients receiving a standard therapy. Patients treated with the Taxotere-based regimen prior to radiation (with or without a surgical component) had a significantly longer median overall survival compared with a standard treatment of cisplatin and fluorouracil (18.6 versus 14.2 months), with a 29 percent risk reduction of death, a benefit of more than four months improvement in median survival. In the study, induction chemotherapy (also called neoadjuvant therapy) was the first step in treating the disease prior to radiation therapy or surgical intervention.

After the recent positive opinion given by the European authorities for the use of Taxotere in inoperable, locally advanced head and neck cancer, this approval marks the 10th indication for Taxotere (the seventh in the United States), which is already approved for use in the treatment of some of the most common cancers. The drug is also approved for metastatic breast cancer, operable node-positive breast cancer, non-small-cell lung cancer and hormone-refractory metastatic prostate cancer.