(Reuters) -The U.S. health regulator’s staff on Tuesday flagged concerns that the late-stage trial data on Geron’s 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)
