The FDA rapidly approved Bristol Myers Squibb’s Opdivo for early-stage NSCLC, marking a major advancement in pre-surgical cancer treatment.

On February 28, the FDA accepted Bristol Myers Squibb’s application for a new use of Opdivo, a checkpoint inhibitor, for early-stage non-small cell lung cancer (NSCLC), with a decision expected by July 13. Surprisingly, the FDA granted approval in just five days, marking a significant milestone for early-stage lung cancer treatment. Opdivo is now approved for use before surgery in these patients, expanding the reach of PD-(L)1 drugs, which have already improved survival in more advanced stages by enabling the immune system to attack cancer more effectively.

This approval represents a notable victory for Bristol Myers Squibb in the competitive checkpoint inhibitor market. Despite being the first to market with a PD-(L)1 drug, Bristol Myers Squibb had fallen behind Merck, which had achieved substantial success in treating advanced NSCLC. The Phase III trial leading to Opdivo’s approval showed that patients receiving Opdivo alongside chemotherapy went a median of 31.6 months without recurrence, significantly longer than the 20.8 months for those receiving chemotherapy alone. Additionally, nearly a quarter of the Opdivo group experienced a pathologic complete response, indicating no detectable cancer, compared to just 2.2% in the chemo-only group.

The early approval of Opdivo for NSCLC is a pivotal development in cancer treatment, with implications for how resectable NSCLC is managed. Merck and other pharmaceutical companies, such as Roche, are also conducting trials to position their PD-(L)1 inhibitors for early-stage treatment across various cancers. The competition is intensifying to establish these drugs as the standard of care in earlier lines of therapy, not just for lung cancer but for other cancer types as well.

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