Pfizer announced that the Food and Drug Administration (FDA) has approved Daurismo (glasdegib) tablets for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults aged ≥75 years who have comorbidities that preclude use of intensive induction chemotherapy. It is intended for use with low-dose cytarabine (LDAC). 

Daurismo, an oral once-daily therapy, is the first Hedgehog pathway inhibitor approved to treat AML. The treatment was evaluated in the Phase 2 BRIGHT 1003 trial which randomized newly-diagnosed AML patients to receive Daurismo + LDAC (N=77) or LDAC alone (N=38) until disease progression or unacceptable toxicity. The efficacy endpoint was overall survival (OS) from date of randomization to death from any cause; median follow-up was approximately 20 months. Patients in the Daurismo + LDAC group had a median OS of 8.3 months vs 4.3 months in LDAC alone group, demonstrating a 54% reduced risk of death for patients in the Daurismo + LDAC group (hazard ratio [HR] 0.46 95% CI, 0.30, 0.71; P =.0002).  

“The randomized Phase 2 study, which formed the basis for today’s approval, included patients with cardiac disease or mild to moderate kidney disease, who are often excluded from clinical trials,” said Jorge Cortes, MD, deputy chair and professor of medicine in the Department of Leukemia, University of Texas, MD Anderson Cancer Center.

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The most common adverse events (≥20% occurrence) in the first 90 days of therapy included anemia, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash. Daurismo carries a Boxed Warning to advise about embryo-fetal toxicity. The drug has not been studied in patients with severe renal impairment or moderate-to-severe hepatic impairment. 

Daurismo will be available as 25mg tablets in 60-count bottles and 100mg tablets in 30-count bottles.

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