US FDA seeks more rigorous trials for cancer drugs' accelerated nod

TG Therapeutics

24/03/2023 15:02

March 24 (Reuters) - The U.S. health regulator on Friday
proposed cancer drug developers conduct more rigorous trials in
order to seek accelerated approval for their therapy candidates.
    The Food and Drug Administration proposed using the
gold-standard "randomized controlled trials" (RCT) where
patients receive either a therapy or another alternate
treatment, compared to conducting a trial testing only the drug
without a comparator. 
    Drug developers usually conduct such "single-arm" studies to
gain accelerated approval, and then hold another trial after 
approval to confirm its clinical benefits.
    The approach of conducting an RCT would be beneficial, as a
longer term follow-up of the same trial after receiving
accelerated approval could fulfill a post-marketing requirement
to verify clinical benefit while also providing a quicker
verification and reducing uncertainty, the FDA said.
    The proposed changes come on the back of accelerated
approvals for cancer drugs by TG Therapeutics  TGTX.O  and Eli
Lilly and Co  LLY.N  being withdrawn in recent years.

 (Reporting by Leroy Leo in Bengaluru; Editing by Maju Samuel)
 ((Leroy.Dsouza@thomsonreuters.com ; Twitter: https://twitter.com/LeroyLeo7;))