FDA Grants Glasdegib Priority Review for Frontline AML

June 27, 2018 – 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 priority review is based on data from the phase II BRIGHT 1003 study, in which combining glasdegib with low-dose cytarabine (LDAC) reduced the risk of death by … (leggi tutto)