Richard Pazdur, director of the FDA's Oncology Center of Excellence (via AACR)
April 18, 2022 11:34 AM EDT
FDA+

When OS is the 'ul­ti­mate safe­ty end­point': FDA lead­ers ques­tion sin­gle-arm tri­als amid scruti­ny of PI3K drugs for blood can­cer

Amber Tong

Is the saga of PI3K in­hibitors in hema­to­log­i­cal ma­lig­nan­cies spurring a re­think at the FDA about ac­cel­er­at­ed ap­provals and the reg­u­la­tion of blood can­cer drugs …

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