Bristol Myers Squibb receives positive CHMP opinion for Opdivo treatment
Ella Day | April 4, 2025 | News story | Research and Development | CHMP, Oncology, bristol myers squibb, immunotherapy, lung cancer, opdivo
Bristol Myers Squibb (BMS) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for its immunotherapy drug Opdivo (nivolumab), marking a major step towards expanding treatment options for patients with resectable non-small cell lung cancer (NSCLC) in the EU.
CHMP, part of the European Medicines Agency (EMA), has recommended approval of Opdivo in combination with platinum-based chemotherapy as a neoadjuvant (pre-surgery) treatment, followed by Opdivo monotherapy after surgery. This perioperative regimen is intended for adult patients with resectable NSCLC whose tumors express PD-L1, a biomarker linked to immune system response.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to harness the body’s immune system to restore anti-tumour immune response. It has quickly become an important treatment for several cancers, especially early-stage lung cancer.
The CHMP’s recommendation is based on data from the phase 3 CheckMate-77T trial, which showed the regimen significantly improved event-free survival (EFS) – the trial’s primary endpoint – compared to chemotherapy alone.
This marks the second Opdivo-based regimen BMS has brought forward for resectable NSCLC. The company’s broader Opdivo development programme has involved over 35,000 patients worldwide and deepened scientific understanding of how biomarkers like PD-L1 influence treatment outcomes.
Lung cancer is the leading cause of cancer deaths globally. NSCLC is one of the most common types of lung cancer, representing almost 84% of diagnoses.
Dana Walker, vice president and Opdivo global programme lead at BMS, said: “Preventing disease recurrence and improving long-term outcomes for patients with NSCLC earlier in the treatment journey is critical. With today’s positive CHMP opinion, we are one step closer to providing another important treatment option for patients in the EU.”
Ella Day
4/4/25
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