PRINCETON, N.J. — Bristol Myers Squibb said the European Commission approved Opdivo in combination with doxorubicin, vinblastine and dacarbazine for adults and adolescents 12 and older with previously untreated Stage III or IV classical Hodgkin lymphoma.
The company said the approval makes Opdivo plus AVD the first immunotherapy-based regimen available in the European Union for newly diagnosed advanced classical Hodgkin lymphoma.
The approval follows a U.S. Food and Drug Administration approval in March 2026 for Opdivo in combination with AVD for previously untreated Stage III or IV classical Hodgkin lymphoma in adults and pediatric patients 12 and older. Bristol Myers Squibb said the European Commission also approved Opdivo earlier this year in combination with brentuximab vedotin for certain children, adolescents and young adults with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy.
“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,” said Monica Shaw, M.D., senior vice president of oncology commercialization at Bristol Myers Squibb. “For decades, patients newly diagnosed with this aggressive blood cancer have faced intensive treatment approaches. 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.”
The approval is based on data from the Phase 3 SWOG 1826 trial, also known as CA2098UT. The study showed that Opdivo plus AVD reduced the risk of disease progression or death by 58% compared with brentuximab vedotin plus AVD, as determined by investigators. The hazard ratio was 0.42, with a 95% confidence interval of 0.27 to 0.67 and a p-value of less than 0.0001.
The trial met its primary endpoint of progression-free survival after a median follow-up of 13.7 months in the intent-to-treat population. After a median follow-up of 36.7 months, median overall survival had not been reached in either treatment arm. Bristol Myers Squibb said there were 26 deaths overall, including nine deaths, or 1.8%, in the Opdivo plus AVD arm and 17 deaths, or 3.4%, in the brentuximab vedotin plus AVD arm.
“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, M.D., Ph.D., 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.”
The European Commission approval is valid in all 27 EU member states, as well as Iceland, Liechtenstein and Norway.
SWOG 1826 is a randomized, multicenter Phase 3 study evaluating Opdivo in combination with AVD in adults and pediatric patients 12 and older with previously untreated Stage III or IV classical Hodgkin lymphoma. The trial’s primary endpoint is progression-free survival, with key secondary endpoints including overall survival and other measures of efficacy and safety.
The study is sponsored by the National Cancer Institute, part of the National Institutes of Health, under a Cooperative Research and Development Agreement with Bristol Myers Squibb. It is being conducted in the NCI National Clinical Trials Network, led by the SWOG Cancer Research Network in collaboration with the Children’s Oncology Group. Bristol Myers Squibb co-sponsored the study and supplied Opdivo to the NCI.
