FDA Approves Glasdegib for First-Line Use in AML

The Food and Drug Administration (FDA) has approved the hedgehog pathway inhibitor glasdegib (Daurismo) for use in combination with low-dose cytarabine (LDAC) for the treatment of acute myeloid leukemia (AML) in newly-diagnosed patients who are aged 75 years or older or who are ineligible for intensive chemotherapy.

The approval was based on a randomized study of 111 patients in which the combination of glasdegib plus LDAC achieved a median overall survival (OS) of 8.3 months versus 4.3 months with LDAC alone.

“Intensive chemotherapy is usually used to control AML, but many adults with AML are unable to have intensive chemotherapy because of its toxicities. Today’s approval gives health care providers another tool to use in the treatment of AML patients with various, unique needs. Clinical trials showed that overall survival was improved using Daurismo in combination with LDAC compared to LDAC alone for patients who would not tolerate intensive chemotherapy,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

According to the FDA, common adverse events occurring in patients receiving glasdegib in clinical trials include anemia, fatigue, hemorrhage, febrile neutropenia, muscle pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash.

This article was originally published by OncLive® as “FDA Approves Glasdegib for Frontline AML.”