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ARTICLE | Clinical News

FDA approves two drugs for first-line AML

November 30, 2018 6:25 PM UTC

FDA approved on Nov. 28 two drugs for first-line treatment of acute myelogenous leukemia, setting off a race in a setting that's been void of new approvals for patients who do not harbor an FMS-like tyrosine kinase 3 (FLT3; CD135) or isocitrate dehydrogenase 1 (IDH1) mutation. The agency also accepted for Priority Review an NDA for a third AML candidate.

FDA approved Daurismo glasdegib from Pfizer Inc. (NYSE:PFE) for use in combination with low-dose cytarabine, and Venclexta venetoclax from AbbVie Inc. (NYSE:ABBV) and Genentech Inc. for use in combination with low-dose cytarabine, azacitidine or decitabine. Both drugs are indicated for newly diagnosed AML in adults who are at least 75 years old or who have comorbidities that may preclude the use of intensive chemotherapy...