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FDA Approves Glasdegib for Frontline AML

Jason M. Broderick @jasoncology
Published: Wednesday, Nov 21, 2018

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

“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 healthcare 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.
US FDA approves Daurismo™ (glasdegib) for Adult Patients With Newly-Diagnosed Acute Myeloid Leukemia (AML) for Whom Intensive Chemotherapy Is Not an Option. Pfizer. Published online November 21, 2018. Accessed November 21, 2018.

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