India, March 14 -- Geron Corp. (GERN) said Thursday that the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee or ODAC 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 or LR-MDS who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents or ESAs.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024 for Geron's New Drug Application for imetelstat for the treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes, who have failed...