FDA Approves New Myeloid Treatment

FDA has approved Pfizer’s Daurismo (glasdegib) tablets for use in combination with low-dose cytarabine to treat newly-diagnosed acute myeloid leukemia (AML) in adults age 75 or older or who have other chronic health conditions or diseases that may preclude use of intensive chemotherapy. An agency news release says Daurismo’s efficacy was studied in a clinical trial in which 111 adult patients with newly diagnosed AML were treated with either Daurismo in combination with low-dose cytarabine or low-dose cytarabine alone. FDA says results showed a significant improvement in overall survival in patients treated with Daurismo.

Common side effects reported by patients receiving Daurismo were anemia, fatigue, hemorrhage, febrile neutropenia, muscle pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash.

The drug’s labeling includes a Boxed Warning on the risk of embryo-fetal death or severe birth defects.