Overview
- The FDA, which authorized the all-oral combination Wednesday, limited use to newly diagnosed adults who are at least 75 or unable to receive intensive induction chemotherapy.
- The decision relied on the phase 2 ASCERTAIN-V study, which reported a 41.6% complete response rate with a median two-month time to response.
- At 11.2 months of follow-up, investigators reported a 46.5% complete response rate and a median overall survival of 15.5 months.
- Safety findings were substantial, with adverse events in 99% of patients, grade 3 or worse events in 98%, treatment interruptions in 68.3%, and fatal events in 15.8%.
- Experts said the oral option could improve quality of life and outpatient care for older patients and may emerge as a new standard for those ineligible for intensive chemotherapy.