Pfizer Receives Positive CHMP Opinion for DAURISMOTM (glasdegib)for Certain Adult Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)
NEW YORK, N.Y., May 1 – Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for DAURISMOTM(glasdegib), a Hedgehog pathway inhibitor, in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly diagnosed (de novo or secondary) acute myeloid leukemia (AML) in adult patients who are not candidates for standard chemotherapy.