In late December 2020, Bristol Myers Squibb Company announced it was withdrawing an accelerated approval indication for the PD-1 inhibitor Opdivo (nivolumuab) in third-line small cell lung cancer because two confirmatory trials failed to meet their overall survival primary endpoints.
Accelerated Approval Withdrawals: Will Non-Oncology Indications Stop ‘Dangling’ In 2024?
While at least 25 accelerated approval cancer indications or drugs have been pulled or requested withdrawn since 2020, there has not yet been a similar concerted regulatory effort in the non-oncology space despite a large number of products with overdue postmarketing requirements.
