EMEA and FDA extend drug-label based on results of the EORTC 2...( In its September meeting 2006 the Com...)

EMEA and FDA extend drug-label based on results of the EORTC 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."

This drug label extension of Taxotere (docetaxel) was possible due to the EORTC 24971 phase III, open label randomized trial, involving 358 patients, evaluating the benefit derived from docetaxel - based combination in inoperable locally advanced head and neck cancer.

Patients treated with the regimen prior to surgery or radiation had significantly longer median overall survival compared to a standard treatment of cisplatin and 5-fluorouracil; with a 28 percent risk reduction of the, 18.6 vs 14.5 months (p=0.0128). Patients receiving the docetaxel-based regimen also had a significantly longer time-to-disease progression of 11.4 months, compared with 8.3 months (P=0.015) for the patients receiving standard therapy. These results have been associated to an improvement of the safety profile.

"Very few treatment options are currently available for patients with head and neck cancer", said Jan B. Vermorken, MD, PhD, Head of Oncology Department, University Hospital Antwerp and Chair of the EORTC Head and Neck Cancer Group and Principal Investigator of the EORTC 24971 study. "EORTC 24971/TAX 323 is the first study to identify a neoadjuvant chemotherapy regimen that extended life for patients with inoperable head and neck cancer; so a
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Contact: Nicole Heine
nicole.heine@eortc.be
32-277-41651
European Organisation for Research and Treatment of Cancer
20-Oct-2006

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