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Geron’s Potential Blockbuster Imetelstat Faces Unexpected AdComm In MDS

Before 2024 PDUFA Date

 
• By Ayisha Sharma

Geron’s highly anticipated telomerase inhibitor has been given a user fee date by the US Food and Drug Administration next year and will also be subject to an advisory committee meeting, despite largely positive analyst sentiment on clinical results to date.  

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.

  • Imetelstat has blockbuster potential in MDS, where it could reach peak sales of $1.2bn.

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

In an unexpected twist, 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

Imetelstat is designed to stop the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies

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