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FDA Approves Glasdegib in Combination With Chemotherapy for Older Patients With AML
The FDA has approved the use of glasdegib (Daurismo; Pfizer) tablets in combination with low-dose cytarabine for the treatment of adults aged ≥75 years with newly diagnosed acute myeloid leukemia (AML) or patients with AML whose comorbidities prevent the use of intensive induction chemotherapy. This indication was approved under the FDA’s priority review process, and received orphan drug designation.
“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,” said Richard Paxdur, MD, Director, FDA Oncology Center of Excellence, in a press release.
This approval was based on a multicenter, open-label clinical trial of 111 patients with newly diagnosed AML who were randomized in a 2:1 ratio to receive glasdegib 100 mg daily plus low-dose cytarabine 20 mg subcutaneously twice daily on days 1 to 10 of a 28-day cycle or low-dose cytarabine alone in 28-day cycles until disease progression or unacceptable toxicity occurred.
Results showed a significant improvement in overall survival in patients treated with glasdegib plus low-dose cytarabine versus low-dose cytarabine alone. The median overall survival was 8.3 months compared with 4.3 months, respectively.
The most common adverse events associated with glasdegib include anemia, fatigure, hemorrhage, febrile neutropenia, muscle pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation or rash.—Janelle Bradley
