Geron Corporation has announced that the European Commission has granted marketing authorization for RYTELO (imetelstat) as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to lower-risk myelodysplastic syndromes (LR-MDS).
Key Highlights:
- RYTELO is the first and only telomerase inhibitor approved in the U.S. and Europe for LR-MDS.
- Approval is for adult patients with transfusion-dependent anemia due to LR-MDS without an isolated deletion 5q cytogenetic abnormality.
- RYTELO has been shown to reduce the need for red blood cell transfusions in patients with LR-MDS.
- The marketing authorization applies to all 27 European Union member states, and Iceland, Norway, and Liechtenstein.
- Geron plans to commercialize RYTELO in select EU countries beginning in 2026, pending country-by-country reimbursement.
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