- An update of PREA called the RACE for Children Act (RACE), which would expand the number of pediatric cancer drug treatments in development, passed the US Senate following House approval and heads to the President’s desk for signing.
The advocacy group Kids v. Cancer (KvC) announced in a press release how the RACE act can promote positive changes in pediatric cancer research by opening more lines of research access.
There are currently around 900 cancer drugs in development for adults, whereas drugs for children are greatly underdeveloped. If enacted as law, the RACE act to authorize the FDA to require companies developing cancer drugs for adults to also develop the drugs for children with cancer.
The group expressed praise for the bipartisan efforts in the House and Senate in getting the bill to its current stage.
“We are grateful to our champions in Congress: Senators Michael Bennet and Marco Rubio and Chairman Lamar Alexander and Ranking Democrat Patty Murray in the Senate; and Representatives Michael McCaul and G.K. Butterfield and Chairman Greg Walden and Ranking Democrat Frank Pallone in the House,” KvC said.
“This could not have been done without their leadership and commitment and without the extraordinary efforts of their able staff.”
KvC stated that once the law took into effect, kids with cancer will have more novel drugs and clinical trials open to them. Other expansions include new information access that pediatric oncologists will have about cancer drugs that might help their kids, what the dosage of the drugs should be, and whether the drugs are safe.
Previously, PREA did not account for cancer drugs because pediatric cancer occurs based on DNA changes early in life, unlike adult cancers that are mostly caused by environmental risk factors.
The RACE law updates PREA by requiring drug development companies to undertake PREA studies of their drugs in children, when the molecular target of their drug is relevant to a child’s cancer. The updates also would end the exemption of PREA obligations for cancer drugs with orphan designations if the molecular target of their drug is relevant to a child’s cancer.
KvC also expressed its gratitude to the FDA for its input at congressional hearings and discussions in regard to the bill’s technicalities.