FDA approves Sanofi's Taxotere for head and neck cancer

The pharmaceutical company, Sanofi-Aventis announced Monday that the U.S. health regulators have given their approval to its anti-cancer drug Taxotere to treat a new form of disease. The drug can now be used for the treatment of locally advanced head and neck cancer prior to chemo-radiotherapy and surgery.

France based Sanofi-Aventis said that the U.S. Food and Drug Administration (FDA) has approved a new application for its big-selling cancer drug Taxotere, which is already approved for the four types of cancers: breast, prostate, lung and gastric.

The US health watchdog approved French pharmaceutical firm’s 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 federal regulators based their approval on the results of the phase III randomized, 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 Sanofi-Aventis’ anti-cancer drug Taxotere in conjunction with just medicines to treat cancer, cisplatin and 5-fluorouracil, slashed their risk of death by 30 percent 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.

Including the head and neck cancer, Taxotere, the company's fourth best-selling drug, is now approved to treat five different tumour types in Europe and the US.

"The approval of Taxotere to be given in combination with other standard chemotherapy as the first step in a therapeutic sequence followed by chemoradiotherapy and surgery is a significant advancement in treatment for patients with locally advanced head and neck cancer," said Marshall Posner, Medical Director of the Head and Neck Oncology Program at Dana-Farber Cancer Institute, in a press release.

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

The drug maker described the head and neck cancer on its Website 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. The company engages in the research, development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but they also develop over-the-counter medication.

Sanofi-Aventis' shares were down 0.8% or EUR0.44 to EUR58.94 in a lower Paris market.