Sanofi aventis gets CHMP backing for Taxotere

Sanofi-aventis has announced that the European Medicines Agency’s Commission for Medicinal Products for Human Use (CHMP) has given its backing to Taxotere.

Taxotere, the injection concentrate, has been given a “positive opinion recommending approval” for use in Europe in association with cisplatin and 5-fluorouracil for the treatment of metastatic stomach cancer.

Today’s recommendation from the CHMP follows news yesterday that the US Food and Drug Administration had approved Taxotere for use.

Opinion was formed following the Tax 325 study, which yielded a 23 per cent reduction in death risk when Taxotere was used in combination with cisplatin and 5-fluorouracil as opposed to when the two were used for treatment without Taxotere.

“This additional indication for a Taxotere-based regimen will represent a new reference treatment for metastatic gastric cancer patients in this very difficult disease,” said Professor Eric Van Cutsen from the University Hospital of Gasthuisberg, Leuven, Belgium, the principal European investigator regarding the Tax 325 trial.

“With an optimal treatment option and appropriate risk management of this Taxotere-based regimen, physicians will now have a more effective therapeutic strategy for their patients.”

More than 934,000 patients worldwide are diagnosed with stomach cancer every year, according to sanofi-aventis.

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