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FDA Approves Frontline Venetoclax in AML

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

The FDA has granted an accelerated approval to venetoclax (Venclexta) for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of adult patients with newly-diagnosed acute myeloid leukemia (AML) who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

The accelerated approval of venetoclax in AML is contingent on the results of a confirmatory trial.
FDA Prescribing Information for Venetoclax. Accessed November 21, 2018.

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