(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changes come on the back of accelerated approvals for cancer drugs by TG Therapeutics and Eli Lilly and Co being withdrawn in recent years.
(Reporting by Leroy Leo in Bengaluru; Editing by Maju Samuel)
