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Geron’s Imetelstat Headed To US FDA Advisory Committee For MDS

 
• By Ayisha Sharma

Geron’s telomerase inhibitor will also get standard review for transfusion-dependent anemia in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS), suggesting FDA reviewers may be less bullish on imetelstat’s clinical data than analysts have been.

red blood cells
Around 50% Of MDS Patients Experience Thrombocytopenia • Source: Shutterstock
Key Takeaways:

  • The AdComm meeting will take place prior to the drug’s PDUFA date of 16 June 2024.

  • Geron was hoping for priority review in MDS.

  • Analysts had expected a smooth approval pathway given strong efficacy results, although some concerns about safety and manufacturing remained.

In a disappointment, Geron Corporation’s first-in-class telomerase inhibitor imetelstat for anemia in patients with lower risk myelodysplastic syndromes (MDS) will be subject to a US Food and Drug

Geron had been seeking priority review for imetelstat, which is designed to stop the uncontrolled proliferation of malignant stem and

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