CHMP backs Xalkori

EMA's CHMP issued several positive opinions on Friday, including recommending conditional approval of Xalkori crizotinib from Pfizer Inc. (NYSE:PFE) to treat previously treated, advanced non-small cell lung cancer (NSCLC) in patients whose tumors are anaplastic lymphoma kinase ( ALK)-positive. Last year, FDA granted accelerated approval to the dual inhibitor of c-Met receptor tyrosine kinase and ALK and their oncogenic variants.

The committee also backed Dacogen decitabine from Johnson & Johnson (NYSE:JNJ) to treat acute myelogenous leukemia (AML). J&J has ex-North American rights to Dacogen from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523), which has rights from Astex Pharmaceuticals Inc. (NASDAQ:ASTX). Astex was up $0.30 (14%) to $2.52 on Friday. In March, FDA issued a complete response letter for an sNDA from Eisai for Dacogen to treat AML. The hypomethylating agent is approved to treat myelodysplastic syndromes (MDS) in the U.S. ...