The sanofi-aventis Group has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has granted a positive opinion for Taxotere (docetaxel) injection concentrate in combination with a current classic treatment as induction treatment for patients with inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN) also referred as head and neck cancer (H&NC). This additional new drug application is also currently under priority review by the Food and Drug Administration.
The supplemental application is based on data from the EORTC 24971/TAX 323 phase III, open-label randomized trial, involving 358 patients evaluating the benefice derived from Taxotere based combination in inoperable locally advanced head and neck cancer. In this study, induction therapy (also called neoadjuvant therapy) is the first step in treating the disease prior to radiation therapy or surgical intervention, a company press release stated.
Patients treated with Taxotere - based regimen prior to surgery or radiation had a significantly longer median overall survival compared to a standard treatment of cisplatin and 5-fluorouraci, with a 28 per cent risk reduction of death.
"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 head of the EORTC section on Head and Neck cancer and Principal investigator of the EORTC 24971/TAX323 study. "This is the first study to identify a neoadjuvant chemotherapy regimen that extended life for patients with inoperable head and neck cancer, so a European approval may offer physicians another treatment option to manage this disease."