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ARTICLE | Regulation

PI3K inhibitor survival data raise cancer trial design questions

FDA’s ODAC to discuss the regulatory pathway for PI3K inhibitors this week

April 19, 2022 10:39 PM UTC

An FDA advisory committee will discuss the future of the toxic yet effective class of PI3K inhibitors this week, and the meeting could have broader implications for oncology drug development. 

Thursday’s meeting of FDA’s Oncologic Drugs Advisory Committee will officially discuss whether randomized data with an overall survival assessment should be required for approval of PI3K inhibitors for hematological malignancies. ...

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