Saturday, 17 November 2012

EMA Committee Recommends Zytiga Before Chemotherapy

The European Medicines Agency (EMA) advisory body the CHMP have recommended Zytiga for use before chemotherapy in treating prostate cancer. This paves the way for final EMA approval which is expected soon. Zytiga is also undergoing consideration by the FDA for use before chemotherapy. This will help thousands of men who have been looking forward to this approval.

CHMP backed expanding the label of Zytiga (abiraterone acetate) to include treatment in combination with prednisone or prednisolone of chemotherapy-na├»ve patients with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly asymptomatic after failing androgen deprivation therapy. Zytiga is under Priority Review by the FDA for this indication in the US, with a decision date expected in December. Zytiga is already approved in the US and EU in combination with prednisone to treat metastatic CRPC patients who have received prior chemotherapy containing docetaxel.

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