Bristol Myers Squibb (NYSE:BMY) has secured approval from the European Commission for the use of Opdivo (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) as a first-line treatment for adults and adolescents aged 12 years and older with previously untreated Stage III or Stage IV classical Hodgkin lymphoma.
The decision introduces the first immunotherapy-based treatment regimen approved in the European Union for patients newly diagnosed with advanced classical Hodgkin lymphoma.
Approval Follows Recent U.S. Authorization
The European authorization comes just months after U.S. regulators approved the same Opdivo-based combination in March 2026, further expanding the drug’s role in the treatment of blood cancers.
Bristol Myers Squibb said the latest approval broadens access to an immunotherapy-driven approach for eligible patients across Europe.
Phase 3 Study Demonstrated Significant Clinical Benefit
The European Commission based its decision on findings from the Phase 3 SWOG 1826 clinical trial, which compared Opdivo plus AVD against brentuximab vedotin plus AVD in patients with advanced classical Hodgkin lymphoma.
Study results showed that the Opdivo combination reduced the risk of disease progression or death by 58% relative to the comparator regimen.
The trial reported a hazard ratio of 0.42, with a 95% confidence interval ranging from 0.27 to 0.67, highlighting a substantial improvement in progression-free outcomes.
Survival Outcomes Remain Encouraging
After a median follow-up period of 36.7 months, median overall survival had not yet been reached in either treatment group.
Researchers recorded a total of 26 deaths during the study, including nine among patients receiving Opdivo plus AVD and 17 among those treated with the comparator regimen.
The data suggest a favorable long-term benefit profile for the immunotherapy-based treatment approach, although patient follow-up remains ongoing.
Most Common Form of Hodgkin Lymphoma
Classical Hodgkin lymphoma represents approximately 95% of all Hodgkin lymphoma diagnoses and is most frequently identified in young adults and older adults.
The disease is also the most commonly diagnosed cancer among adolescents between the ages of 15 and 19, underscoring the importance of expanding treatment options for younger patient populations.
Approval Covers the Entire European Economic Area
According to the company, the European Commission approval applies across all 27 European Union member states.
The authorization also extends to Iceland, Liechtenstein and Norway, allowing eligible patients throughout the European Economic Area to access the newly approved Opdivo-based regimen.