Analyzing two decades of trends in FDA approvals for GI cancer treatments

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Fares Jamal, MD, Mayo Clinic Comprehensive Cancer Center, Rochester, MN, provides insight into the evolving trends of FDA approvals for GI cancer treatments from 2006 to 2024. Findings showed a significant increase in approvals in the later period (2015-2024) and a rise in accelerated approvals and Phase II, single-arm studies. Overall survival remained the most common endpoint, but objective response rate was used more frequently during the later period. Using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS), substantial clinical benefit was shown to increase over time. Dr Jamal highlights the need to balance efficacy, toxicity, and financial burden while optimizing approval pathways to improve patient outcomes and treatment accessibility. This interview took place at the ASCO GI Cancers Symposium 2025 in San Francisco, CA.

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Category
Oncology
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