Sanofi-Aventis has won US approval to extend the approved uses of its cancer drug Taxotere to include patients with stomach cancer.
The US Food and Drug Administration has cleared Taxotere (docetaxel) for use in combination with cisplatin and 5-fluorouracil in patients with advanced cases of the disease. Shortly after the FDA’s decision, Taxotere was recommended for approval in the same indication in the European Union.
Sanofi-Aventis said it is the first FDA approval of an advanced stomach cancer treatment demonstrating a survival advantage in more than a decade.
Taxotere is already used for treating breast, lung and prostate cancer, and is Sanofi-Aventis’ third biggest-selling product, bringing in sales of 1.61 billion euros ($1.93bn) last year.