Incyte’s Retifanlimab Tests US FDA’s Tolerance For Low Response Rates In Accelerated Approval
US FDA advisory committee votes 13-4 to wait for Phase III data in anal cancer, expected in 2025.
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Biotech sponsors understandably discuss accelerated approval as an important consideration in development plans. But the head of the US FDA oncology program has a reminder for them: the pathway is intended to serve patients – not drug companies.
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.
EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.