This approval marks a significant milestone, establishing the Opdivo plus AVD combination as the first immunotherapy-based regimen available in the European Union (EU) for newly diagnosed advanced cHL.1

This new EC approval reinforces the expanding impact of Opdivo in cHL, building upon the U.S. Food and Drug Administration (FDA) approval of Opdivo in combination with AVD for previously untreated Stage III or IV cHL in adults and pediatric patients 12 years and older, granted in March 2026.2 Earlier this year, the EC also approved Opdivo in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents, and adults up to 30 years of age with relapsed or refractory cHL after one prior line of therapy.1

"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, MD, senior vice president of Oncology Commercialization, Bristol Myers Squibb. "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."

The EC approval is based on data from the Phase 3 SWOG 1826 (Study CA2098UT) which demonstrated a 58% reduction in the risk of disease progression or death with Opdivo in combination with AVD versus brentuximab vedotin plus AVD, as determined per investigator (Hazard Ratio [HR] 0.42; 95% Confidence Interval [CI] 0.27-0.67; P=<0.0001).The trial demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS), based on a median follow-up of 13.7 months in the intent to treat population. After a median follow-up of 36.7 months, the median overall survival (OS) had not been reached in either treatment arm with a total of 26 deaths: 9 (1.8%) deaths in the Opdivo in combination with AVD arm and 17 (3.4%) deaths in the standard of care over brentuximab vedotin plus AVD arm.5

"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, MD, PhD, 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."

This approval by the EC for Opdivo plus AVD for the treatment of adult and adolescent patients 12 years of age and older with previously untreated Stage III or IV cHL is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein and Norway. In addition to this approval in cHL, Opdivo-based options are also approved for treatment of multiple tumor types in the EU.

Bristol Myers Squibb thanks the SWOG Can