ERIBULIN AND CABAZITAXEL WILL SOON BE APPROVED BY EMEA

European Medicines Agency adopts positive opinions for eribulin and cabazitaxel

21.01.11

Category: Scientific News

Meeting highlights from the Committee for Medicinal Products for Human Use

The European Medicines Agency Committee for Medicinal Products for Human Use at its January 2011 meeting adopted positive opinions recommending the granting of marketing authorizations for the following new medicines:

• Halaven (eribulin), from Eisai Europe Ltd, intended for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. The review for Halaven began on 26 May 2010 with an active review time of 180 days.
• Jevtana (cabazitaxel), from Sanofi-aventis, intended in combination with prednisone or prednisolone for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. The review for Jevtana began on 26 May 2010 with an active review time of 208 days.