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CHMP backs approval of Mylotarg, Alpivab, Kineret

February 24, 2018 12:15 AM UTC

EMA's CHMP announced a spate of opinions Friday, including positive recommendations for Mylotarg gemtuzumab ozogamicin, Alpivab peramivir and Kineret anakinra, as well as the expected negative opinion for Nerlynx neratinib.

The committee recommended approval of Mylotarg from Pfizer Inc. (NYSE:PFE) in combination with daunorubicin and cytarabine to treat previously untreated, CD33-positive acute myelogenous leukemia (AML), except acute promyelocytic leukemia (APL), in patients ages 15 and older...