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Rx For Immuno-Oncology Excess? Top US FDA Cancer Officials Take On Development ‘Wild West’

 
• By Bridget Silverman

Rapid, uncoordinated growth has turned the PD-1/L1 inhibitor pipeline into a global stampede, FDA’s Pazdur and Beaver say. Solutions like a unified submission pathway and coordinated trial design pose challenges requiring international cooperation among governments and industry alike.

Gang of cowboys riding horses on wild west film set, Fort Bravo, Tabernas, Almeria, Spain - Image ID: EY250G (Alamy)
Julia Beaver and Richard Pazdur hope to clean up immuno-oncology development town. • Source: Alamy

International regulatory coordination toward a “unified regulatory submission pathway” for immuno-oncology drugs could foster more rational use of resources, two FDA Oncology Center of Excellence officials propose in the New England Journal of Medicine – but they note that the US FDA lacks the ability to enforce changes unilaterally.

The “unbridled and rapid growth” of the PD-1/L1 inhibitor class has resulted in “a stampede of commercial sponsors, clinical trials and redundant development plans,” Oncology Center of Excellence acting deputy director Julia Beaver and director Richard Pazdur reported in the NEJM perspective article published 15 December 2021 under the title

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