This marks the 10th indication for the drug.
Sanofi-aventis’ Taxotere® (docetaxel) Injection Concentrate has been approved in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable, locally advanced, squamous cell carcinoma of the head and neck (SCCHN). The company reports that this approval marks the 10th indication for Taxotere in the world and seventh in the U.S., where it is already approved for use in the treatment of some of the most common cancers.
The FDA based its decision on results from the EORTC 24971/TAX 323 Phase III, open-label, randomized study, which enrolled 358 patients with SCCHN. “Survival rates for advanced head and neck cancer have historically been low,” points out Marshall Posner, M.D., who led the team that designed the trial and is medical director of the head and neck oncology program at Dana-Farber Cancer Institute in Boston. “This study has shown that induction therapy with a Taxotere, cisplatin, fluorouracil (TPF) regimen increases survival. With this approval, I hope to see TPF become the standard of care for induction therapy for patients with this type of cancer.”
Patients receiving the Taxotere-based regimen (Taxotere, cisplatin and fluorouracil) had a progression-free survival of 11.4 months, compared with 8.3 months for the patients receiving a standard therapy. The Taxotere-based regimen group, prior to radiation, had a median overall survival of 18.6 months as opposed to the group that got cisplatin and fluorouracil where survival was 14.2 months. Sanofi-aventis also found a 29% risk reduction of death, a benefit of more than four months improvement in median survival.