FDA approved a supplemental New Drug Application to update the U.S. Prescribing Information for Tibsovo, an isocitrate dehydrogenase-1 inhibitor, to include adult patients with newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
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.
