Geron reports FDA advisors vote in favor of benefit/risk of imetelstat

Geron announced that the U.S. Food and Drug Administration (FDA) 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 who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents. “We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS. There are few treatment options and significant unmet medical need remains for these patients, particularly among those with difficult-to-treat subtypes of this blood cancer. We believe that imetelstat has the potential to be an important new medicine for patients and look forward to continuing our collaboration with the FDA as they complete their review of our New Drug Application,” said Faye Feller, M.D., Geron’s Executive Vice President, Chief Medical Officer. The FDA assigned a Prescription Drug User Fee Act, or PDUFA, target action date of June 16 for Geron’s New Drug Application for imetelstat for the treatment of TD anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes, who have failed to respond, or have lost response to, or are ineligible for ESAs. “The ODAC provides the FDA with independent opinions and recommendations from outside medical experts, patients and caregivers, though the recommendations are not binding. Geron plans to commercially launch imetelstat in the U.S. upon potential FDA approval,” the company stated.