Geron’s RYTELO™ (imetelstat) FDA Approved for Lower-Risk MDS Patients with Anemia

Geron Corporation (Nasdaq: GERN) has received FDA approval for RYTELO™ (imetelstat), a groundbreaking treatment for adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) suffering from transfusion-dependent (TD) anemia. This approval signifies a significant advancement in addressing the unmet medical needs of these patients who have not responded to or are ineligible for erythropoiesis-stimulating agents (ESA).

Dr. John A. Scarlett, Geron’s Chairman and Chief Executive Officer, expressed optimism regarding the potential clinical benefits of RYTELO for eligible patients with lower-risk MDS. He emphasized the innovative nature of RYTELO as the first telomerase inhibitor, attributing its approval to the company’s dedication to scientific excellence and innovation in blood cancer treatment.

Lower-risk myelodysplastic syndromes (LR-MDS) pose significant challenges for patients, often leading to transfusion dependency and symptomatic anemia. The approval of RYTELO offers a promising treatment option for these patients, potentially providing over 24 weeks of freedom from the burden of red blood cell transfusions and symptomatic anemia.

The approval of RYTELO is based on positive results from the IMerge Phase 3 clinical trial, which demonstrated its efficacy in achieving red blood cell transfusion independence (RBC-TI) for at least eight consecutive weeks and up to 24 weeks. Additionally, RYTELO showed sustained and durable RBC-TI, with a median duration of approximately one to 1.5 years for responders.

Dr. Rami Komrokji, Vice Chair of the Malignant Hematology Department at Moffitt Cancer Center and an investigator in the IMerge trial, highlighted the transformative potential of RYTELO in improving outcomes for LR-MDS patients. He emphasized the clinical benefit observed across key MDS subgroups, regardless of baseline characteristics.

The safety profile of RYTELO was well-characterized in the IMerge trial, with manageable cytopenias being the most common adverse reactions. These included thrombocytopenia and neutropenia, which were generally short-lived and resolved with dose modifications. The intravenous administration of RYTELO aligns with routine blood count monitoring for these patients.

Overall, the FDA approval of RYTELO represents a significant milestone in the treatment landscape for lower-risk MDS patients with transfusion-dependent anemia, offering new hope and potential for improved clinical outcomes.

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