13 December 2024 - Geron Corporation today announced that the CHMP of the EMA has adopted a positive opinion recommending the approval of Rytelo (imetelstat) for the treatment of adult patients with transfusion-dependent anaemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

As part of its review of the marketing authorisation application, the CHMP looked at the results from the IMerge Phase 3 clinical trial and assessed that the benefit of Rytelo in patients with transfusion-dependent anaemia due to very low, low or intermediate risk myelodysplastic syndrome is a reduction in the need for red blood cell transfusions in the first 24 weeks of treatment compared to placebo, as observed in the double-blind controlled study.

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