GERN - FDA ODAC Votes in Favor of Geron's Imetelstat Clinical Benefit/Risk Profile for the Treatment of certain Transfusion-Dependent Anemia Patients

2024-03-15 09:34:33 ET

DENVER, Colo., Mar 15, 2024 ( 247marketnews.com )- Geron Corporation (NASDAQ: GERN ) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat, based on results from the IMerge Phase 3 clinical trial, for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs).

“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,” said Faye Feller, M.D., Geron’s Executive Vice President, Chief Medical Officer. “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.”

The move follows the ODAC IMerge Phase 3 clinical trial results review, as the primary endpoint of red blood cell transfusion independence (RBC-TI) for at least eight consecutive weeks was significantly higher with imetelstat vs. placebo (p<0.001), with median RBC-TI duration approaching one year for imetelstat ?8-week RBC-TI responders.

Geron plans to kick off imetelstat’s US commercial launch following potential FDA approval and the FDA’s Prescription Drug User Fee Act (PDUFA) target action date is scheduled for June 16, 2024.

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