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Do FDA-approved Cancer Drugs Really Take 6 Years to Reach Children?

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Do FDA-approved Cancer Drugs Really Take 6 Years to Reach Children? 
 
This 2019 article discusses the delay at the time in making FDA-approved cancer drugs available to children. A study co-authored by Steven G. DuBois, MD, of Harvard Medical School and the Dana-Farber Cancer Institute found that oncology drugs take a median of 6.5 years to progress from first-in-human to first-in-child clinical trials. Of 117 cancer drugs approved between 1997 and 2017, only 6 had initial pediatric indications, while 15 had never been tested in children. DuBois noted that the RACE for Children Act should help reduce these delays by requiring pediatric studies for certain targeted cancer drugs.

Recommendations:

  • Increase funding for pediatric cancer research
  • Provide incentives for pharmaceutical companies to develop pediatric cancer treatments
  • Expand pediatric clinical trial networks to improve patient recruitment

Perspective:    Funding for certain aspects of childhood cancer has increased through programs such as the Childhood Cancer STAR Act and the Childhood Cancer Data Initiative.  Incentive programs like the Rare Pediatric Disease Priority Review Voucher (renewed recently) encourage pharmaceutical investment in pediatric treatments.  Consolidated pediatric cancer clinical trial networks,  we hope, will recruit patients more efficiently across hundreds of sites.

Conclusion:   Although progress is being made, children with cancer have faced longstanding delays in accessing new treatments. Renewed investment in research, incentives, and clinical trial expansion would help ensure that innovative therapies reach pediatric patients more quickly.

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