FDA Approves Glasdegib for Patients With Newly Diagnosed AML Who Cannot Undergo Intensive Chemotherapy
Today, the U.S. Food and Drug Administration (FDA) approved glasdegib (Daurismo) tablets to be used in combination with low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or with comorbidities that may preclude the use of intensive chemotherapy. Glasdegib is the first and now the only FDA-approved Hedgehog pathway inhibitor for AML.
“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 [glasdegib] in combination with [low-dose cytarabine] compared to [low-dose cytarabine] alone for patients who would not tolerate intensive chemotherapy,” said 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. Almost half of the adults diagnosed with AML are not treated with intensive chemotherapy because of comorbidities and chemotherapy-related toxicities.
BRIGHT 1003 Trial
The efficacy of glasdegib was studied in the randomized, phase II BRIGHT 1003 clinical trial, in which 111 adult patients with newly diagnosed AML were treated with either glasdegib in combination with low-dose cytarabine or low-dose cytarabine alone. The trial measured overall survival from the date of randomization to death from any cause.
Results demonstrated a significant improvement in overall survival in patients treated with glasdegib—the median overall survival was 8.3 months for patients treated with glasdegib plus low-dose cytarabine compared with 4.3 months for patients treated with low-dose cytarabine only.
Common side effects reported by 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. Glasdesgib must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Patients should also be advised not to donate blood or blood products during treatment. Health-care providers should also monitor patients for QT prolongation.
The FDA granted this application Priority Review and Orphan Drug designation.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
