RALEIGH, N.C., June 19 (Bernama-GLOBE NEWSWIRE ) — Between 2007-2017, 78 novel adult cancer agents were approved by the U.S. Food and Drug Administration,¹ but none of those drugs were researched to determine effectiveness for pediatric cancers.
That is about to change on August 18 when the RACE Act – The Research to Accelerate Cures and Equity for Children Act – goes into effect. Passed in 2017, the RACE Act amends the existing PREA – Pediatric Research Equity Act – and eliminates the exemption from PREA requirements for cancer drugs that have orphan status. The new law requires pediatric evaluation of new drugs and biologics intended for the treatment of adult cancers and directed at a molecular target substantially relevant to the growth or progression of pediatric cancer.