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.
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US FDA contemplating how to match orphan designation process with drug development moving to molecularly-targeted therapies.
Phase I/II data from Opdivo/Yervoy combination in SCLC provide more evidence that tumor mutation burden is emerging as a biomarker for immunotherapy, but commercial value is unclear and results don't have implications for the all-important CheckMate 227 non-small cell lung cancer trial, analysts say.