Geron's blood disorder drug gets FDA advisers' backing (updated)

Geron

14/03/2024 19:33

(Adds details in paragraph 2 and background in paragraphs 3 to
5)
       March 14 (Reuters) - Advisers to the U.S. Food and Drug
Administration on Thursday voted in favor of Geron's  GERN.O 
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)
 ((Pratik.Jain@thomsonreuters.com;))