Another accelerated approval rowback in immuno-oncology

26 July 2021

The latest voluntary withdrawal stemming from the US regulator’s review of accelerated approvals is Bristol Myers Squibb’s (NYSE: BMY) nod for Opdivo (nivolumab) in liver cancer.

The decision follows an earlier withdrawal for the checkpoint blocker, in late 2020, in small cell lung cancer (SCLC).

Several other drugmakers have been affected by the US Food and Drug Administration’s decision to take a fresh look at accelerated approvals which have not met post-marketing requirements.

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