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Azacitidine + Venetoclax are approved treatments for certain adults with newly diagnosed acute myeloid leukemia (AML) who are not suitable candidates for intensive chemotherapy.
The U.S. Food and Drug Administration (FDA) granted accelerated approval for the combination of venetoclax with azacitidine, decitabine, or low-dose cytarabine in November 2018. This approval is specifically for adults aged 75 years or older, or for those with medical conditions that preclude the use of intensive chemotherapy. In October 2020, the FDA provided regular approval based on clinical trial data, including results from the VIALE-A trial, which…