European Organization for Research and Treatment of Cancer And FDA Extend Drug-Label Based On Results Of The European Medicines Evaluation Agency 24971 Trial
In its September meeting 2006, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) gave a positive opinion to include the use of docetaxel in combination with the current standard treatment - cisplatin and 5 – fluorouracil – for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck. On October 18, the US Food and Drug Administration (FDA) gave its approval to the new treatment as well. According to Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research, it will "provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patients' survival."