Cancer remains the leading cause of disease-related death in children in the United States. Despite significant progress over the past 25 years, the development of treatments for pediatric oncology has seen only limited success. The US Food and Drug Administration (FDA) has been working to accelerate the development of pediatric cancer drugs, moving from voluntary guidelines to mandatory regulations.
In August 2017, the FDA passed the Research to Accelerate Cures and Equity (RACE) for Children Act as part of the FDA Reauthorization Act (FDARA), signaling a significant shift in the regulatory approach for pediatric oncology drug development. This new law mandates that all marketing applications for new adult oncology drugs, submitted after August 18, 2020, include evaluations of their safety and efficacy in pediatric cancers, provided they share a relevant molecular target.
The RACE Act directly impacts how pediatric oncology drug development should be approached, emphasizing coordination with adult oncology development and the integration of pediatric considerations into broader drug development plans.
Key Takeaways for Sponsors
- Mandatory Pediatric Evaluations for Relevant Adult Drugs
The RACE Act mandates that new adult oncology drugs be evaluated for potential application in pediatric oncology if they share molecular targets relevant to treating pediatric cancers. This change shifts the focus of drug development to ensure treatments are being considered for children from the outset, accelerating the pace of research in this critical area.
- Strategic Coordination Between Adult and Pediatric Oncology Development
Sponsors must plan for pediatric oncology drug development as part of the overall oncology development strategy. This coordination is crucial to ensure that new therapies are being tested for pediatric use alongside their adult counterparts, aligning clinical trials and safety evaluations across both populations.
- Expanded Regulatory Requirements for Pediatric Cancer Treatment
The RACE Act is part of a broader trend of increasing regulatory support for pediatric cancer treatments. Sponsors should expect to align their development timelines, regulatory filings, and clinical trial designs to meet the expanded requirements set by the FDA. This approach will improve the chances of successful pediatric oncology treatments reaching the market faster.
- Focus on Molecular Targets
The law requires a focus on molecular targets that are common between adult and pediatric cancers. Sponsors should ensure they are identifying these targets early in their drug development process to meet the FDA’s requirements under the RACE Act.
How BioBoston Consulting Can Support Your Pediatric Oncology Development Strategy
Navigating the complexities of pediatric oncology drug development under the RACE Act can be challenging, but BioBoston Consulting is here to guide you through the process. Our team of experts can help you develop a strategic approach for your oncology drug development plan that meets regulatory requirements and accelerates the availability of treatments for pediatric patients.
Why Choose BioBoston Consulting?
- In-depth Knowledge: We have extensive experience in oncology regulatory landscapes and can provide insight into how best to align your development plans with the RACE Act.
- End-to-End Support: From drug development strategy to regulatory submissions, we offer tailored solutions to ensure that your product meets pediatric cancer treatment needs.
- Regulatory Expertise: Our team helps you navigate the FDA’s regulatory framework, ensuring that your pediatric oncology trials are compliant and efficient.
If you are preparing to navigate the challenges of pediatric oncology drug development, contact BioBoston Consulting today for expert guidance and solutions tailored to your specific needs. We are dedicated to ensuring that your oncology products reach the right patients, faster.