The European Commission (EC) has granted approval to Bristol Myers Squibb’s (BMS) perioperative regimen of neoadjuvant Opdivo (nivolumab), combined with chemotherapy and followed by adjuvant Opdivo and surgery, for treating resectable non-small cell lung cancer (NSCLC).
The approval targets individuals whose tumours express programmed death ligand 1 (PD-L1) at a level of 1% or higher.
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It is supported by the randomised Phase III CheckMate -77T trial outcomes, which demonstrated significant improvements in event-free survival – the primary endpoint for those at high risk of recurrence.
The trial, which assessed the Opdivo and platinum-doublet chemotherapy regimen against neoadjuvant platinum-doublet chemotherapy and placebo, showed a 42% decrease in disease recurrence, progression or mortality risk.
Subjects treated with Opdivo experienced better outcomes after a median follow-up of 25.4 months.
This approval is applicable across all 27 European Union (EU) member states, along with Iceland, Norway and Liechtenstein.
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By GlobalDataOpdivo aims to leverage the body’s immune system to combat tumour growth. Since its initial regulatory approval in July 2014, the therapy is authorised for use in 65 nations and regions, including the US, the European Union (EU), China and Japan.
Alongside lung cancer, Opdivo-based options have secured approvals for treating various types of tumours in the EU.
Bristol Myers Squibb Opdivo global programme lead Dana Walker stated: “This approval brings another perioperative immunotherapy treatment option for select patients with resectable NSCLC in the EU, helping address an ongoing need for interventions that can meaningfully reduce the risk of cancer returning after initial therapy.
“With this approval, Opdivo with chemotherapy followed by adjuvant Opdivo has the potential to change the course of certain patients’ disease by significantly reducing the risk of cancer recurrence and improving long-term outcomes earlier in the treatment journey.”
In May 2025, the company announced a significant investment of $40bn in the US to enhance research and manufacturing capabilities up to 2029.
