FDA Approves New Treatment for Patients With AML Who Cannot Undergo Intensive Chemotherapy

The U.S. Food and Drug Administration approved glasdegib in combination with low-dose cytarabine (LDAC) for patients with newly-diagnosed acute myeloid leukemia (AML) who are ≥75 years old or who may be unable to undergo intensive chemotherapy due to comorbidities. 

The decision was based on results of a randomized clinical trial that included 111 adult patients with newly diagnosed AML who received glasdegib in combination with LDAC or LDAC alone. Patients receiving glasdegib combination had a significant improvement in overall survival (median = 8.3 months) compared with patients treated with LDAC alone (median = 4.3 months). 

The most common adverse events associated with glasdegib are anemia, fatigue, hemorrhage, febrile neutropenia, muscle pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash. 

Glasdegib has a Boxed Warning about the risk of embryo-fetal death or severe birth defects; women who are pregnant or breast feeding should not take glasdegib. Pregnancy testing should be conducted in females of reproductive age prior to initiation of glasdegib, and effective contraception should be used during treatment and for at least 30 days after the last dose. The Boxed Warning also advises male patients of the potential risk of drug exposure through semen and to use condoms with a pregnant or female partner who could become pregnant both during treatment and for at least 30 days after the last dose.  

Patients should not donate blood or blood products during treatment with glasdegib. Healthcare providers should monitor patients for QT prolongation. 

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Source: FDA