(Reuters) -Advisers to the U.S. Food and Drug Administration on Thursday voted in favor of Geron’s blood disorder drug,stating that, based on late-stage trial data, the benefits outweigh treatment associated risks in patients.
Among the 14 panel members, 12 backed the benefits of imetelstat, saying it outweighs the associated safety risks of the drug, while 2 voted against its use in patients.
Geron is seeking approval to use imetelstat for treating transfusion-dependent anemia in patients with a group of blood cancers called myelodysplastic syndromes (MDS).
The FDA’s advisory panel meeting followed a review from the agency’s staff on Tuesday, who raised multiple safety concerns with the treatment.
The regulator, which usually follows the advice of its panel but is not bound to do so, is expected to make a decision on the drug by June 16.
(Reporting by Pratik Jain and Christy Santhosh in Bengaluru; Editing by Krishna Chandra Eluri)
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