Global pharma powerhouse Bristol Myers Squibb has announced a major breakthrough for classical Hodgkin Lymphoma (cHL) patients, as Opdivo (nivolumab) secured approval for two new indications in the United States and European Union.

 

In the US, the Food and Drug Administration (FDA) approved Opdivo in combination with AVD (doxorubicin, vinblastine, dacarbazine) for adults and pediatric patients aged 12 and older with previously untreated Stage III or IV cHL. Across the Atlantic, the European Commission greenlit Opdivo with brentuximab vedotin for children aged 5 and older, adolescents, and adults up to 30 with relapsed or refractory cHL following one prior therapy.

 

“These approvals represent a defining moment for people living with classical Hodgkin Lymphoma,” said Monica Shaw, 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. 

 

"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. These milestones reflect our continued commitment to advancing science that meaningfully improves the lives of patients and families worldwide.”

 

The US approval stems from the Phase 3 SWOG 1826 study, which demonstrated a 58% reduction in the risk of disease progression or death for patients receiving Opdivo plus AVD. The trial showed a statistically significant improvement in progression-free survival, with median follow-up of 13.7 months, and overall survival data still pending after 36.7 months.

 

“For decades, treatment approaches in classical Hodgkin Lymphoma have presented significant challenges, both for newly diagnosed patients and those facing relapse,” said Alex Herrera, Chief of Division of Lymphoma at 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.”

 

Gwen Nichols, Chief Medical Officer of Blood Cancer United, emphasized the human impact: “The availability of another treatment option for people living with certain types of Hodgkin lymphoma can make a real difference. 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 approval is based on the Phase 2 CheckMate-744 study evaluating Opdivo with brentuximab vedotin for relapsed or refractory cHL in younger patients and adults up to 30 years old.