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CHMP recommends Zaltrap

November 17, 2012 12:55 AM UTC

EMA's CHMP issued several positive opinions on Friday, including recommending approval of Zaltrap ziv-aflibercept from Sanofi (Euronext:SAN; NYSE:SNY) in combination with FOLFIRI chemotherapy to treat metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. Sanofi is co-developing Zaltrap, which is approved in the U.S. for the indication, with Regeneron Pharmaceuticals Inc. (NASDAQ:REGN).

CHMP also backed expanding the label of Zytiga abiraterone acetate from Johnson & Johnson (NYSE:JNJ) to include treatment in combination with prednisone or prednisolone of chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly asymptomatic after failing androgen deprivation therapy. The recommendation includes a new contraindication of severe hepatic impairment. Zytiga is under Priority Review for the indication in the U.S., with an undisclosed PDUFA date in mid-December. Zytiga is approved in the U.S. and EU in combination with prednisone to treat metastatic CRPC patients who have received prior chemotherapy containing docetaxel. ...