U.S. FDA declines to approve Y-mAbs's pediatric cancer drug (updated)

Y-mAbs Therapeutics

01/12/2022 23:00

(Adds details from company's statement, background, updates
share move)
       Dec 1 (Reuters) - 
    The U.S. health regulator on Thursday declined to approve a
treatment from Y-mAbs Therapeutics  YMAB.O  for a rare form of
nerve cancer in pediatric patients, dragging the company's
shares 16% lower in extended trading.
        Y-mAbs said it is assessing the implications of the Food
and Drug Administration's complete response letter and the
company's plans for the development program for the drug,
omburtamab.
  
    The FDA's decision follows a unanimous vote by its advisers
in October against the drug to treat neuroblastoma due to
insufficient evidence that it improves overall survival.
    The company had asked the FDA to review data from its
clinical trials that did not compare the drug to another
treatment, as is the case with cancer trials traditionally.
    The FDA and its advisers had raised issues over the strength
of the data and uncertainty over trial results. 
 (Reporting by Aditya Samal and Leroy Leo in Bengaluru; Editing
by Sriraj Kalluvila and Maju Samuel)
 ((Aditya.Samal@thomsonreuters.com;))