FDA grants Priority Review to Pfizer's glasdegib for AML

Pfizer Inc. (NYSE:PFE) said FDA accepted and granted Priority Review to an NDA for glasdegib (PF-04449913) to treat previously untreated acute myelogenous leukemia (AML) in combination with low-dose cytarabine. The PDUFA date is in December.

The NDA is based on data from the Phase II BRIGHT 1003 trial in which glasdegib plus low-dose cytarabine met the primary endpoint of improving median overall survival (OS) vs. cytarabine alone (8.8 vs. 4.9 months, HR=0.501, 95% CI: 0.334, 0.752, one-sided p=0.0003)...