US FDA staff flags concerns about Geron's anemia treatment (updated)

Geron

12/03/2024 13:53

(Adds details from FDA document)
       March 12 (Reuters) - The U.S. health regulator's staff
on Tuesday flagged concerns that the late-stage trial data on
Geron's  GERN.O  anemia drug does not show whether the risks of
treatment with imetelstat are outweighed by the potential
benefit, documents released ahead of a meeting of independent
experts showed.
    The injectable drug imetelstat was being studied in patients
with lower risk myelodysplastic syndromes (MDS), a type of blood
cancer, which requires frequent blood transfusions for managing
anemia.
    The Food and Drug Administration (FDA) raised concerns about
the duration in which patients achieved red blood cell
transfusion independence (RBC-TI).
    The FDA staff said the clinical meaningfulness of an 8-week
RBC-TI period in the context of lower risk MDS is uncertain as
the general consensus among MDS experts has been that only a
16-week or longer period of transfusion independence is
clinically meaningful.

 (Reporting by Christy Santhosh and Pratik Jain in Bengaluru;
Editing by Shailesh Kuber)
 ((Christy.Santhosh@thomsonreuters.com;))