FDA approves Geron’s Rytelo for treatment of MDS with transfusion-dependent anaemia
Betsy Goodfellow | June 7, 2024 | News story | Medical Communications | FDA, Geron, Haematology, anaemia, mds
Geron Corporation has announced that the US Food and Drug Administration (FDA) has approved Rytelo (imetelstat) for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anaemia who require at least four red blood cell units over eight weeks and who have not responded, or lost response to, or are ineligible for erythtopoiesus-stimulating agents (ESA).
This approval follows results from the phase 3 IMerge clinical trial, full results from which were published in The Lancet. The trial met its primary and key secondary endpoints, showing significantly higher rates of red blood cell transfusion independence compared to placebo for at least eight consecutive weeks.
John A Scarlett MD, Geron’s chairman and chief executive officer, commented: “With the approval and availability of Rytelo, we believe eligible patients with lower-risk MDS can potentially experience meaningful clinical benefit, particularly the potential for greater than 24 weeks of freedom from the burden of red blood cell transfusions and symptomatic anaemia. The approval of Rytelo as the first telomerase inhibitor is a testament to the power of our science and the passion of our people to innovate in the field of blood cancer. As we celebrate today’s momentous milestone, I would like to thank the patients and families, advocates, clinicians, study coordinators and site personnel, scientists and Geron employees and collaborators past and present whose participation was integral to this achievement, and to supporting our transformation into a commercial company.”
Betsy Goodfellow
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