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Washington, D.C. — U.S. Senators Marco Rubio (R-FL) and Michael Bennet (D-CO) introduced the Give Kids a Chance Act. The bill would ensure that children with cancer can participate in not only single-drug trials, but also combination therapy trials. It would also require the U.S. Food and Drug Administration (FDA) to analyze the collection of preclinical data and better utilize existing clinical data to determine potential pediatric uses of drugs.
“Child cancer patients should have every chance possible to beat this nightmare disease,” Rubio said. “We cannot let outdated bureaucratic hurdles block innovative and potentially life-saving treatments. No family should ever have to experience the horrific pain of losing a child, and I will push for this bill to become law this year.”
“Cancer doctors and medical professionals should have every tool at their disposal to treat kids who are battling pediatric cancer,” Bennet said. “Our bipartisan legislation will make sure cutting-edge trials and combination therapies are available to treat this disease and improve outcomes for our kids. I look forward to working with my colleagues to get this done as we keep fighting to end cancer as we know it.”
“Our Children’s Hospital Colorado team of oncology experts cares for and helps develop ground-breaking treatments for children, adolescents, and young adults with the most difficult cancer diagnoses in Colorado and across the country. The patient and families we serve should have every chance for the best and most innovative care and treatments to help them sustain a high quality of life. Senators Bennet and Rubio’s Give Kids A Chance Act will build on their prior work to pass the RACE for Children Act and increase access to combinations of targeted cancer drugs. We are grateful for their commitment to the children and families who need most new treatment options, and we urge Congress to pass the legislation as soon as possible,” Lia Gore, MD, Section Head, Pediatric Hematology/Oncology/BMT at Children’s Hospital Colorado, said.
Background:
The bill would authorize the FDA to require pediatric studies to combine certain molecularly-targeted oncology drugs or biologics to determine if the combination of therapies can help treat the growth and progression of pediatric cancer. Combination therapy trials have proven successful in adults with cancer, especially in preventing relapse. Most pediatric cancer patients that are currently participating in drug trials have relapsed cancers.
El texto de la carta en inglés está Give Kids a Chance Act builds on Rubio and Bennet’s RACE for Children Act, which was signed into law as part of the Prescription Drug and User Fee Authorization (PDUFA) Act in 2017. That law amended the Pediatric Research Equity Act (PREA) to expedite the approval of pediatric oncology drugs.
El texto de la carta en inglés está RACE for Children Act was instrumental in ensuring oncology single-drug trials also included a pediatric study. The law has helped generate data on molecular targets that are safe and effective in treating the growth and progression of pediatric cancer. The Give Kids a Chance Act would further amend PREA to require pediatric studies of certain molecular-targeted oncology drugs or biologics in combination.
Related:
July 14, 2016: Rubio, Colleagues Introduce “RACE For Children Act” To Boost Pediatric Cancer Research