The FDA approved glasdegib, in combination with low-dose cytarabine, for patients with newly diagnosed AML who are aged 75 years or older or who have comorbidities that preclude the use of intensive induction chemotherapy.
The agency’s decision was based on results from the multicenter, open-label BRIGHT AML 1003 study, which included 115 patients with AML who met the following criteria: 75 years or older, severe cardiac disease, Eastern Cooperative Oncology Group performance status score ≤2, or baseline serum creatinine >1.3 mg/dL.
Patients were randomized 2:1 to receive glasdegib 100 mg/day with low-dose cytarabine (20 mg subcutaneously twice daily on days 1 to 10 of a 28-day cycle; n=77) or low-dose cytarabine alone (n=38).
With a median follow-up of 20 months, median overall survival was 8.3 months (range = 4.4-12.2 months) for the glasdegib arm and 4.3 months (range= 1.9-5.7 months) for the cytarabine-alone arm (hazard ratio = 0.46; 95% CI 0.30-0.71; p=0.0002).
The most common AEs (occurring in ≥20% of patients) included anemia, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash.
Source: FDA news release, November 23, 2018.