Cures II Wish List: Reconsidering Accelerated Approval?
Richard Pazdur wants the oncology community to take a fresh look at US FDA’s expedited review programs. One big question: should there be fewer of them?
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Oncology ‘Beyond Breakthrough’ Takes Shape: FDA Project Will Create Benefits ‘Menu,’ Rescission Process
US FDA’s oncology team has come to realize that a better understanding of how to personalize its ‘all-hands-on-deck’ approach would be even more helpful – especially for first-time sponsors.
Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals leads to removal of indications for two PD-1/L-1 inhibitors, AstraZeneca’s Imfinzi and Bristol-Myers Squibb’s Opdivo, both of which had failed confirmatory trials.
Top officials want confirmatory trials to finish in a ‘reasonable amount of time’ and worry that ‘if 100% of them were able to confirm, then the bar’s too high.’