FDA okays Sanofi-Aventis's Taxotere for head and neck cancer

4 October, 2007

The United States Food and Drug Administration (FDA) has given its approval to anti-cancer drug Taxotere to treat a new form of the disease.

Taxotere, manufactured by French pharmaceutical group Sanofi-Aventis, can now be used for the treatment of locally advanced head and neck cancer prior to chemo-radiotherapy and surgery.

Sanofi-Aventis said Taxotere has already been approved for four types of cancers: breast, prostate, lung, and gastric.

The FDA approved the chemotherapy agent Taxotere (docetaxel) in combination with Platinol (cisplatin) and 5-fluorouracil as induction therapy for locally advanced squamous cell carcinoma of the head and neck (SCCHN) before patients undergo chemo-radiotherapy and surgery.

The FDA based its approval on the results of the phase III randomised, open-label, international trial, TAX 324, which established the efficacy and safety of the Taxotere-based regimen in significantly improving survival in patients with locally advanced SCCHN.

The results of this clinical trial showed that the addition of Taxotere to standard induction chemotherapy resulted in a more than three-year improvement in patient survival rate. The overall survival in patients who received Taxotere-based therapy was significantly improved compared to those treated with just cisplatin and 5-fluorouracil.

Cancer patients who received Taxotere in conjunction with just medicines to treat cancer, cisplatin and 5-fluorouracil, reduced their risk of death by 30% when compared to the group which received just the anti-cancer medicines.

The survival in the Taxotere-based therapy group was 70.6 months when compared with 30.1 months in the latter group.

Taxotere, Sanofi-Aventis’ fourth best-selling drug, is now approved to treat five different tumour types in Europe and the United States, including cancers of the head and neck.

According to Sanofi-Aventis, over 640,000 people around the world are diagnosed with head and neck cancer each year, and the disease takes more than 350,000 lives each year.

The company described the head and neck cancer as a group of many related diseases that mostly begin in the cells that line the mucosal surfaces in the head and neck area such as the mouth, tongue, tonsils, throat, and voicebox. The term includes cancers of the oral cavity, salivary glands, paranasal sinuses, and nasal cavity, pharynx, and larynx.

Sanofi-Aventis, one of the five largest pharmaceutical companies in the world after Pfizer, Bristol-Myers Squibb, Novartis, and GlaxoSmithKline, is headquartered in Paris, France.