12:40 PM
 | 
Nov 21, 2018
 |  BC Extra  |  Company News

FDA approves two drugs for first-line AML

FDA approved on Wednesday 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...

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