A new law, introduced by U.S. Rep. Michael McCaul, R-Austin, and a group of bipartisan lawmakers, could make it easier for children with cancer to battle the disease with the help of adult cancer drugs.
The Research to Accelerate Cures and Equity for Children Act – or RACE for Children Act – gives the U.S. Food and Drug Administration authority to require that adult cancer drugs be studied for safety and effectiveness in children battling the disease. President Donald Trump signed the legislation Friday.
The law is part of a larger effort to spur more cancer research and treatment, McCaul said. Congress recently reauthorized the Creating Hope Act of 2011, a voucher program that gives incentives to pharmaceutical companies to develop new drugs for children battling rare diseases.
Earlier this year, McCaul reintroduced the Childhood Cancer Survivorship, Treatment, Access and Research Act, or Childhood Cancer STAR Act, which “would improve efforts to identify and track childhood cancer incidences, improve the quality of life for childhood cancer survivors, and identify opportunities to expand the research of therapeutics necessary to treat the approximately 15,700 children diagnosed with cancer in the U.S. every year,” according to his office.
Among others, the Creating Hope Act has helped Austin-area child Rex Ryan, who was diagnosed with Stage 4 neuroblastoma cancer at 17 months and was treated with the drug Unituxin in 2014.
“It’s the No. 1 killer of our children,” McCaul told the American-Statesman on Monday. “This is completely bipartisan … getting something done for our kids.”
The recently signed law updates the 2003 Pediatric Research Equity Act, “which requires studies of adult drugs in children during the drug development process,” according to a statement from McCaul’s office late last week.
“While PREA has been successful in hundreds of cases in providing critical information on a drug’s use in children, it has never been applied to a cancer drug,” according to the statement. “RACE gives the FDA the authority to require a pediatric investigation into an adult drug if it uses molecular targeting, and the same target is ‘substantively relevant’ to the growth of a pediatric cancer.”
The new law is a “huge accomplishment” for the pediatric cancer community, George Dahlman, CEO of Children’s Cause for Cancer Advocacy, told the Statesman.
Though there’s more improvements to be made, “this has been a key objective for years,” he added.