Venetoclax received its third Breakthrough Therapy Designation from the FDA, for a combination treatment with hypomethylating agents for patients with untreated acute myeloid leukemia who are ineligible to receive standard induction therapy.
In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.
