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FDA Grants Glasdegib Priority Review for Frontline AML

Jason M. Broderick @jasoncology
Published: Wednesday, Jun 27, 2018

Dr. Mace Rothenberg
Mace Rothenberg, MD
The FDA has granted a priority review to a new drug application (NDA) for glasdegib for use in combination with chemotherapy for the frontline treatment of patients with acute myeloid leukemia (AML), according to Pfizer, the developer of the investigational oral smoothened (SMO) inhibitor.

The ongoing phase III BRIGHT AML 1019 trial (NCT03416179) is examining glasdegib combined with intensive or nonintensive chemotherapy in treatment-naïve patients with AML.
Cortes JE, et al. A phase II randomized study of low dose Ara-C with or without glasdegib (PF-04449913) in untreated patients with AML or High-Risk MDS. Presented at: 58th ASH Annual Meeting and Exposition; December 3-6, 2016; San Diego, CA. Abstract 99.

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