EU Approves Opdivo Combo for Advanced Hodgkin Lymphoma

Bristol Myers Squibb has received approval from the European Commission for Opdivo® (nivolumab) in combination with the chemotherapy regimen AVD (doxorubicin, vinblastine and dacarbazine) as a first-line treatment for adult and adolescent patients aged 12 years and older with previously untreated Stage III or Stage IV classical Hodgkin lymphoma (cHL).

The approval marks a significant development in the treatment of advanced Hodgkin lymphoma, making Opdivo plus AVD the first immunotherapy-based regimen authorized in the European Union for newly diagnosed advanced-stage cHL. The decision expands treatment options for patients and reflects the growing role of immunotherapy in hematologic cancers.

Classical Hodgkin lymphoma is a type of blood cancer that originates in the lymphatic system. While many patients can achieve remission with existing treatments, advanced-stage disease often requires intensive chemotherapy regimens that can be associated with significant side effects. Researchers and clinicians have increasingly focused on integrating immunotherapy into frontline treatment strategies to improve outcomes while maintaining tolerability.

The European Commission’s approval is based on results from the Phase III SWOG 1826 clinical trial, which compared Opdivo plus AVD with the current standard treatment regimen of brentuximab vedotin plus AVD in patients with newly diagnosed advanced cHL.

The study demonstrated a statistically significant improvement in progression-free survival, the trial’s primary endpoint. Investigators reported that patients treated with the Opdivo-based regimen experienced a 58% reduction in the risk of disease progression or death compared with those receiving brentuximab vedotin plus AVD. The findings were based on a median follow-up period of 13.7 months in the intent-to-treat population.

Longer-term follow-up data further reinforced the regimen’s potential benefit. After a median follow-up of 36.7 months, overall survival had not yet been reached in either treatment group. However, fewer deaths were reported among patients receiving Opdivo plus AVD, with nine deaths recorded in the immunotherapy arm compared with 17 deaths in the comparator group.

Experts believe the approval could influence future treatment practices across Europe. Franck Morschhauser, Professor of Hematology at the University of Lille and Hospital Claude Huriez, noted that achieving durable remission remains a key goal for patients with advanced Hodgkin lymphoma, particularly adolescents and older adults. He said the SWOG 1826 trial demonstrated meaningful improvements in progression-free survival and highlighted the potential of nivolumab-based therapy to become an important frontline treatment option.

Monica Shaw, Senior Vice President of Oncology Commercialization at Bristol Myers Squibb, described the approval as an important advancement for patients newly diagnosed with advanced classical Hodgkin lymphoma. She emphasized that the decision underscores the expanding role of immunotherapy-based approaches in blood cancers and reflects the company’s commitment to introducing innovative therapies earlier in the treatment journey.

The latest authorization builds on growing regulatory momentum for Opdivo in Hodgkin lymphoma. In March 2026, the U.S. Food and Drug Administration approved Opdivo plus AVD for adults and pediatric patients aged 12 years and older with previously untreated Stage III or IV disease. Earlier this year, European regulators also approved Opdivo in combination with brentuximab vedotin for certain patients with relapsed or refractory classical Hodgkin lymphoma.

The new approval applies across all 27 European Union member states as well as Iceland, Liechtenstein and Norway. Beyond Hodgkin lymphoma, Opdivo-based therapies are already approved in Europe for multiple cancer types, further strengthening the drug’s position as a cornerstone immunotherapy across oncology.

With the introduction of the first immunotherapy-based frontline regimen for advanced classical Hodgkin lymphoma in Europe, physicians and patients now have access to a new treatment approach that may improve disease control and long-term outcomes in this highly curable but potentially aggressive cancer.