BMS Gets First Immunotherapy Approval In Neoadjuvant Lung Cancer, Quickly

Opdivo gets approved by the US FDA for neoadjuvant non-small cell lung cancer, an important new early-stage indication for the anti-PD-1 agent that cleared the agency in roughly two months.

Checkmate
Data from the CheckMate-816 study earns Bristol another indication for Opdivo • Source: Alamy

Bristol Myers Squibb Company’s Opdivo now holds the first immunotherapy approval for neoadjuvant non-small cell lung cancer (NSCLC), giving the firm an important beachhead as it focuses on expanding in the lucrative lung cancer field.

The indication for use with platinum-doublet chemotherapy for adults with resectable NSCLC in the neoadjuvant setting was based on data from the CheckMate-816 trial, and was granted by the US...

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