Bristol Myers Squibb gains EU approval for Opdivo combination in lymphoma

Bristol Myers Squibb (NYSE: BMY) received European Commission approval for Opdivo (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for treating adult and adolescent patients 12 years and older with previously untreated Stage III or IV classical Hodgkin lymphoma.

The approval marks the first immunotherapy-based regimen available in the European Union for newly diagnosed advanced classical Hodgkin lymphoma. The decision follows FDA approval granted in March 2026 for the same combination in the United States.

The European approval was based on data from the Phase 3 SWOG 1826 study, which demonstrated a 58% reduction in the risk of disease progression or death with Opdivo plus AVD versus brentuximab vedotin plus AVD. The trial showed a hazard ratio of 0.42 with a 95% confidence interval of 0.27-0.67.

After a median follow-up of 36.7 months, median overall survival had not been reached in either treatment arm, with 26 total deaths recorded: 9 deaths in the Opdivo combination arm and 17 deaths in the standard of care arm.

Classical Hodgkin lymphoma accounts for 95% of Hodgkin lymphoma cases and is most commonly diagnosed in early adulthood and late adulthood. The disease is the most common cancer diagnosed in adolescents aged 15-19.

The EC approval is valid in all 27 EU member states, as well as Iceland, Liechtenstein and Norway, according to the company's press release.

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