The U.S. Food and Drug Administration (FDA) approved glasdegib in combination with low-dose cytarabine for patients aged 75 years or older with newly diagnosed acute myeloid leukemia (AML), or who have comorbidities that preclude the use of intensive induction chemotherapy.
The approval 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 adverse reactions (≥20%) 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.