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# Geron Myelodysplastic Syndromes NDA Approved
- URL: https://www.fdaweb.com/geron-myelodysplastic-syndromes-nda-approved/
- Published: 2024-06-07T12:00:00.000Z
- Updated: 2026-09-14T14:32:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157135

FDA has approved a Geron NDA for Rytelo (imetelstat) for treating adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks. The company says the therapy is intended for patients who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents. “Lower-risk myelodysplastic syndromes (LR-MDS) is a blood cancer that often progresses to require increasingly intensified management of key symptoms such as anemia and resulting fatigue,” it says.

Approval was based on data from the IMerge Phase 3 clinical trial, according to Geron. The trial met its primary and key secondary endpoints, with Rytelo demonstrating significantly higher rates of red blood cell transfusion independence versus placebo for at least eight consecutive weeks.

Additionally, the trial showed that Rytelo’s safety profile was well-characterized with generally manageable and short-lived thrombocytopenia and neutropenia, Geron says. The most common Grade 3/4 adverse reactions were neutropenia (72%) and thrombocytopenia (65%), which lasted a median duration of less than two weeks, and in more than 80% of patients were resolved to Grade 2 or less in under four weeks.