CHMP recommends approval of Cabazitaxel Accord for metastatic prostate cancer.- Accord Healthcare

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cabazitaxel Accord (cabazitaxel), from Accord Healthcare, intended for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. Cabazitaxel Accord will be available as a 20 mg/ml concentrate for solution for infusion. Cabazitaxel Accord is a hybrid medicine of Jevtana which has been authorised in the EU since 17 March 2011. Cabazitaxel Accord contains the same active substance as Jevtana, but it is available in a different formulation. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.