US FDA's Top Tips For Tumor Agnostic Drug Development

'Although sponsors have conventionally focused on the development of a drug, the strategy of pursuing site-agnostic indications must focus on both drug and biomarker development,' FDA's Richard Pazdur and colleagues write in the New England Journal of Medicine.

Digital illustration of Cancer cell in colour background

The US FDA is advising sponsors to carefully consider the appropriateness for developing drugs across tumor types and to work collaboratively on biomarkers in the wake of the groundbreaking approval of Merck & Co. Inc.'s Keytruda for a "tissue-agnostic" indication.

Merck's PD-1 inhibitor Keytruda (pembrolizumab) won accelerated approval in May for any type of solid tumor that are microsatellite-high (MSI-H)...

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