FDA Advisory Committee Votes in Favor of Geron's Imetelstat for Anemia in Lower-Risk MDS

The FDA Oncologic Drugs Advisory Committee voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS). Geron Corporation's imetelstat, a telomerase inhibitor, demonstrated positive results in the IMerge Phase 3 clinical trial, showing significant improvement in red blood cell transfusion independence and hemoglobin levels. The FDA has set a PDUFA target action date of June 16, 2024 for imetelstat's New Drug Application, and Geron plans to launch imetelstat in the U.S. upon potential FDA approval.