Bristol Myers Squibb has secured a major regulatory win in Europe, as the European Commission approved its cancer drug Opdivo (nivolumab) in combination with AVD chemotherapy for newly diagnosed advanced classical Hodgkin lymphoma in adult patients.
The decision marks a milestone for the company, establishing the Opdivo-AVD regimen as the first immunotherapy-based frontline treatment for Stage III or IV classical Hodgkin lymphoma in the European Union.
The approval is supported by results from the Phase 3 SWOG 1826 trial, which showed a 58% reduction in the risk of disease progression or death versus brentuximab vedotin plus AVD. At a median follow-up of 13.7 months, the study met its primary endpoint of progression-free survival, with a hazard ratio of 0.42.
At 36.7 months of follow-up, overall survival data remained immature, with 26 total deaths reported across both arms.
“For patients with newly diagnosed Stage III or IV classical Hodgkin Lymphoma, finding an effective and tolerable first-line treatment remains crucial to achieving long-term remission, especially for adolescents and the elderly,” said Franck Morschhauser, Professor of Hematology at the University of Lille and Hospital Claude Huriez.
“The SWOG 1826 study provided compelling data demonstrating that nivolumab-based combination therapy significantly improved progression-free survival compared with the standard of care. The availability of the first-ever IO combination in this earlier setting and across a broad spectrum of ages offers a potentially practice-changing approach to the treatment of frontline cHL.”
Bristol Myers Squibb highlighted that the EU decision builds on recent regulatory momentum, including U.S. FDA approval of Opdivo plus AVD earlier this year and a separate EU approval of Opdivo in combination with brentuximab vedotin for relapsed or refractory disease in younger patients.
“Today’s approval of Opdivo in combination with AVD for previously untreated advanced classical Hodgkin Lymphoma marks an important advancement for patients in the European Union,1” said Monica Shaw, senior vice president of Oncology Commercialization at Bristol Myers Squibb.
She added: “For decades, patients newly diagnosed with this aggressive blood cancer have faced intensive treatment approaches.3,4 This approval underscores the benefit and critical role of immunotherapy-based approaches in hematologic cancers like cHL and reflects our continued commitment to bringing these innovative options to patients earlier in their treatment journey across cancer types.”
Opdivo, a PD-1 immune checkpoint inhibitor, is already approved in more than 65 countries and used across multiple tumor types, forming the backbone of Bristol Myers Squibb’s broader oncology strategy.
The company emphasized that the latest approval strengthens its position in immuno-oncology as it continues expanding Opdivo into earlier lines of therapy and across a widening range of cancers.
