Posted by Michael Wonder on 27 Jun 2018
U.S. FDA grants priority review for Pfizer's new drug application for glasdegib in patients with previously untreated acute myeloid leukaemia
27 June 2018 - Submission based on data from randomised Phase 2 trial, which showed glasdegib in combination with chemotherapy nearly doubled overall survival compared to chemotherapy alone.
Pfizer today announced that the U.S. FDA accepted the company’s new drug application and granted priority review designation for glasdegib, an investigational oral smoothened inhibitor, being evaluated for the treatment of adult patients with previously untreated acute myeloid leukaemia (AML) in combination with low-dose cytarabine (LDAC), a type of chemotherapy.
The Prescription Drug User Fee Act goal date for a decision by the FDA is in December 2018.
The submission is based on results from the Phase 2 BRIGHT 1003 study, a randomized, open-label, multicenter trial investigating glasdegib combined with LDAC (n=88) versus LDAC alone (n=44) in 132 patients with previously untreated AML or high-risk myelodysplastic syndrome (MDS) who were not eligible for intensive chemotherapy.
