(HealthDay)—The U.S. Food and Drug Administration recently announced the approval of Daurismo (glasdegib) tablets for use in combination with a low dose of the chemotherapy cytarabine to treat newly diagnosed acute myeloid leukemia (AML). The treatment is indicated for patients aged 75 years or older who have comorbidities that may prevent the use of intensive chemotherapy.
Researchers investigated the efficacy of Daurismo in a randomized clinical trial of 111 adult patients with newly diagnosed AML. Patients were randomly assigned to treatment with Daurismo in combination with low-dose cytarabine or treatment with low-dose cytarabine alone. Data showed a significant improvement in overall survival with Daurismo from the date of random assignment to death from any cause. Median overall survival was 8.3 months for patients treated with Daurismo plus low-dose cytarabine compared with 4.3 months for patients treated with low-dose cytarabine alone.
Commonly reported side effects included anemia, fatigue, hemorrhage, febrile neutropenia, muscle pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash.
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