Generates Pediatric Studies of Cancer Drugs Developed by Molecular Target Therapy for Adults with Cancer
Washington, DC – U.S. Senators Michael Bennet (D-CO) and Marco Rubio (R-FL), along with Representatives Michael T. McCaul (R-TX-10), G. K. Butterfield (D-NC-01), Sean Duffy (R-WI-07), and Chris Van Hollen (D-MD-08), today introduced the RACE for Children Act (the Research to Accelerate Cures and Equity for Children Act) to support the development of novel and promising cancer drugs for children.
The bipartisan bill would update the Pediatric Research Equity Act (PREA) to reflect the latest advances in cancer drugs. PREA was enacted by Congress in 2003 to address the challenge of the scarcity of information about how to treat children with drugs developed for adults and in turn, develop pediatric data during drug development. Although PREA has resulted in new information on how to treat children for a multitude of drugs over the years, there is still limited pediatric studies in cancer drugs.
“Researchers in Colorado and throughout the country are making dramatic advances in the fight to treat and cure cancer. But there has been a lag in the amount of research devoted to pediatric cancers,” Bennet said. “This bill will help use what has been learned from adult cancer research to help treat kids with cancer. It’s a simple update to our laws that has the potential to help save thousands of kids.”
“Childhood cancer touches too many families in Florida, including my own, but modern technology and medical advancements have me more optimistic than ever that cancer as we know it can be defeated in our lifetime. It is important to focus on helping more children overcome cancer in the 21st century, and this legislation I am sponsoring will help,” said Rubio. “I’m proud to introduce the RACE for Children Act to encourage more research into more treatment options so children fighting cancer across our nation will have better chance to beat this disease. I’m especially proud to introduce this bill on behalf of the many advocates, moms, dads and children who have tirelessly fought to get more attention, funding and resources for the fight against pediatric cancer. I look forward to continuing my work with them and other stakeholders to make this important legislation the law of the land.”
“We’ve made great strides in combating childhood cancer, but unfortunately the laws governing childhood cancer research are misaligned with the current science of cancer drug development,” said McCaul. “The RACE for Children Act will modernize the law to provide for pediatric studies on the most promising and innovative treatments. I will continue to work with my colleagues and the advocacy community to find ways to give hope to the nearly 15,000 children and adolescents diagnosed with cancer each year.”
“Pediatric cancer remains the number one cause of disease-related death for children in the United States, surpassing deaths from asthma, diabetes, congenital anomalies, cystic fibrosis, and pediatric AIDS combined. While the cause of childhood cancer remains unknown, advancement in modern technology has allowed us to increase survival rates.” said Butterfield. “I am proud to join my colleagues in the introduction of the RACE for Children Act, which invests in advanced pediatric cancer treatment that will make a tremendous difference in the lives of families in North Carolina and across the country.”
“We can defeat childhood cancer, and the RACE for Children Act will help us get there,” said Duffy. “Our children deserve twenty-first century laws that reflect the latest research and development in our ongoing battle against cancer.”
“Childhood cancer remains the leading cause of death in American children, and the lack of available treatments is a tragedy,” said Chris Van Hollen, Co-Chair of the Childhood Cancer Caucus. “I’m proud to join with my colleagues in introducing The RACE for Children Act, which will help advance research into lifesaving cures. We must continue to work together to combat this deadly disease and to promote the development of new treatments for the nearly 16,000 children who are diagnosed with cancer every year in America.”
PREA does not apply to cancer because children’s cancers arise in different organs than adult cancers, and as a result, most pharmaceutical companies receive waivers from their PREA obligations. However, scientific advances have shown that some childhood and adult cancers may share the same molecular targets, and cancer drug development is now almost uniformly focused on advancements in molecular targets.
The RACE for Children Act would update PREA by reflecting the new and promising approach to cancer drug development using molecular targets. There are two main challenges that prevent the current structure of PREA from working to advance pediatric cancer drug development. PREA applies to specific indications, or specific types of cancers. The legislation would allow PREA to focus on molecular target in a specific adult cancer when the same target presents in another childhood cancer. A PREA exemption may also be applied if the company studies the drug in adult cancer that occurs in less than 200,000 patients. The bill would allow pediatric studies with a particular molecular target still be considered for these cancers.
The bill is supported by the Coalition for Pediatric Medical Research, Children’s Hospital Colorado, Dan-Farber Cancer Institute, Duke University Medical Center, Georgia Regents Health System, Massachusetts General Hospital for Children, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Nemours Children’s Health System, NYU Langone Medical Center, Rady Children’s Hospital – San Diego, St. Jude Children’s Research Hospital, Texas Children’s Hospital, the Children’s Hospital of Philadelphia, and more than 100 pediatric cancer advocacy organizations.