Bristol Myers Squibb’s Opdivo Gains Dual US And EU Approvals In Hodgkin Lymphoma, Opdivo Combinations Deliver Strong Survival Benefits

Bristol Myers Squibb announced that Opdivo® (nivolumab) has secured two new approvals for classical Hodgkin lymphoma (cHL) across the United States and the European Union. The U.S. Food and Drug Administration approved Opdivo in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for adults and pediatric patients aged 12 years and older with previously untreated Stage III or IV cHL. Meanwhile, the European Commission authorised Opdivo with brentuximab vedotin for children aged five and above, adolescents, and adults up to 30 years old with relapsed or refractory disease after one prior therapy.

“For decades, treatment approaches in classical Hodgkin Lymphoma have presented significant challenges, both for newly diagnosed patients and those facing relapse,” said Alex Herrera, M.D., Chief of Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope National Medical Center. “In the U.S., the nivolumab-based combination for patients with previously untreated Stage III or IV cHL demonstrated improved progression-free survival compared with standard of care, BV-AVD. The SWOG 1826 study provides data for frontline use of this immunotherapy-based regimen.”

The U.S. approval is supported by results from the Phase III SWOG 1826 (CA209-8UT) trial, which assessed Opdivo plus AVD in patients with newly diagnosed advanced cHL aged 12 and older. A regulatory submission based on these findings is also under review by the European Medicines Agency.

“The availability of another treatment option for people living with certain types of Hodgkin lymphoma can make a real difference,” says Gwen Nichols, M.D., Chief Medical Officer of Blood Cancer United. “Each new FDA-approved therapy brings renewed hope for patients and their families, and advances like this one signal meaningful progress in improving outcomes for people facing this disease.”

The EU decision is based on the Phase II CheckMate-744 study evaluating Opdivo combined with brentuximab vedotin in younger patients with relapsed or refractory cHL. The study focused on individuals who had received one prior line of treatment.

“These approvals represent a defining moment for people living with classical Hodgkin Lymphoma,” said Monica Shaw, MD, Senior Vice President of Oncology Commercialization. “In the U.S., we are particularly proud that Opdivo in combination with AVD now stands as an immunotherapy combination available for adults and pediatric patients, ages 12 and older, with previously untreated advanced disease.1 Concurrently, in the EU, Opdivo in combination with brentuximab vedotin has also achieved a milestone as the first immunotherapy combination for certain relapsed or refractory patients.2 These milestones reflect our continued commitment to advancing science that meaningfully improves the lives of patients and families worldwide.”

SWOG 1826 demonstrated a 58% reduction in the risk of disease progression or death for patients receiving Opdivo plus AVD compared to the control regimen. The combination delivered a statistically significant improvement in progression-free survival at a median follow-up of 13.7 months. With longer follow-up of 36.7 months, overall survival had not yet been reached in either group, with fewer deaths reported in the Opdivo combination arm compared to the comparator regimen.