FDA Panel Backs Geron's Imetelstat for Lower-Risk MDS Patients

FDA advisory committee voted 12-2 in favor of benefit/risk profile of imetelstat for treating transfusion-dependent anemia in lower-risk MDS patients
Imetelstat achieved high rates of red blood cell transfusion independence compared to placebo in Phase 3 IMerge trial
Clinically meaningful responses seen across difficult-to-treat MDS subgroups with high unmet need
June 16, 2024 is FDA's target action date for potential approval of imetelstat in this indication
Most common Grade 3-4 side effects with imetelstat were manageable thrombocytopenia and neutropenia