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Geron’s Imetelstat Faces Full Gamut Of US FDA Questions At ODAC Meeting

 
• By Derrick Gingery

FDA has efficacy and safety concerns about the proposed anemia treatment and questions whether the results could even apply to US patients given the large number of ex-US study participants.

blood transfusion
The imetelstat advisory committee documents included separate briefings from the FDA and Geron, rather than a combined package. • Source: Shutterstock

Geron Corporation’s imetelstat will face difficult questions on efficacy, safety and even US clinical practice applicability from the US Food and Drug Administration at its Oncologic Drugs Advisory Committee meeting.

Imetelstat, proposed trade name Rytelo, is pending for treatment of transfusion-dependent anemia in adults with low to intermediate-1 risk myelodysplastic syndromes (MDS) who failed to respond, or have lost

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