FDA Approves Geron's Rytelo For Treatment Of Lower-Risk MDS Anemia

(RTTNews) - Geron Corp. (GERN) said that the U.S. Food and Drug Administration has approved Rytelo (imetelstat) for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes or MDS with transfusion-dependent or TD anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents or ESA.

Lower-risk MDS is a progressive blood cancer with high unmet need, where many patients with anemia become dependent on red blood cell transfusions, which can be associated with clinical consequences and decreased quality of life.

The FDA approval of RYTELO was based on results from the IMerge Phase 3 clinical trial. Durable and sustained red blood cell transfusion independence, increases in hemoglobin levels and reduction in transfusion burden observed across key LR-MDS subgroups in the IMerge Phase 3 clinical trial. The most common Grade 3/4 adverse reactions were thrombocytopenia and neutropenia, which were generally manageable and short-lived.

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