FDA Grants Marketing Authorisation To Sanofi-aventis Jevtana Injection

Jevtana, a microtubule inhibitor, in combination with prednisone, was approved based on results from the Phase 3 Tropic clinical study involving 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen.

Results from this trial demonstrated a 30% reduction in risk of death from mHRPC among patients taking Jevtana in combination with prednisone compared with an active chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone.

Sanofi-aventis said that Jevtana is approved in combination with prednisone for the treatment of patients with mHRPC previously treated with a docetaxel-based treatment regimen.

Earlier, Jevtana was granted fast track designation by the FDA in November 2009. The rolling new drug application submission was completed in March 2010 and was granted priority review in April 2010; Jevtana was approved by the FDA less than three months later.

Jevtana is expected to be available as a marketed product in the US in summer 2010. A registration dossier of Jevtana is also under regulatory review by other regulatory authorities, including the European Medicines Agency.

Debasish Roychowdhury, senior vice president of global oncology at sanofi-aventis, said: “This is a proud time for sanofi-aventis Oncology. Phase III study results with Jevtana were significant for a prostate cancer compound since it successfully demonstrated a survival benefit compared to active control in a second-line treatment setting.”