FDA Grants Regular Approval to Venetoclax in Combination for Untreated Acute Myeloid Leukemia in Adults Unable to Receive Intensive Chemotherapy
The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:
On October 16, 2020, the Food and Drug Administration granted regular approval to venetoclax (VENCLEXTA®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for newly-diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy. Read more.