FDA Alert

FDA Approves Opdivo Plus AVD for Previously Untreated Stage III/IV Classical Hodgkin Lymphoma

Edited by:
Ashton L. Stahl

Key Highlights

  • FDA-approved Opdivo (nivolumab) with AVD for previously untreated stage III or IV classical Hodgkin lymphoma in adults and pediatric patients aged 12 years and older.  
  • The approval was supported by results from SWOG 1826, a randomized, open-label, multicenter trial comparing nivolumab plus AVD with brentuximab vedotin plus AVD.  
  • Nivolumab plus AVD improved investigator-assessed progression-free survival versus brentuximab vedotin plus AVD.    
  • The recommended regimen is nivolumab given intravenously on days 1 and 15 of each 28-day cycle for up to 6 cycles, with primary G-CSF prophylaxis starting in cycle 1.  

On March 20, 2026, the FDA approved Opdivo (nivolumab) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma. The agency also granted traditional approval to nivolumab for certain adults with relapsed or refractory classical Hodgkin lymphoma after prior autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or after 3 or more lines of systemic therapy that includes autologous HSCT.  

The approval in the frontline setting was based on Study CA209-8UT (SWOG 1826; NCT03907488), a randomized, open-label, multicenter trial that enrolled 994 patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma. Patients were randomly assigned to receive either nivolumab plus AVD or brentuximab vedotin plus AVD for 6 cycles. The study met its primary endpoint, showing superior investigator-assessed progression-free survival with nivolumab plus AVD (hazard ratio, 0.42; 95% CI, 0.27-0.67; P < .0001). Median progression-free survival was not reached in either arm after a median follow-up of 13.7 months.  

In the nivolumab plus AVD arm, serious adverse reactions occurred in 39% of patients, and immune-mediated adverse reactions occurred in 9%, including grade 3 to 4 immune-mediated adverse reactions in 2.7%.

The recommended nivolumab dose is 240 mg for adults and pediatric patients weighing at least 40 kg, or 3 mg/kg for pediatric patients weighing less than 40 kg. It is administered intravenously with AVD on days 1 and 15 of each 28-day cycle for up to 6 cycles. The FDA said primary G-CSF prophylaxis is recommended beginning in cycle 1. 

The application received priority review and orphan drug designation. The review was conducted under Project Orbis, a framework for concurrent international regulatory review.

Reference

U.S. Food and Drug Administration. FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma. March 20, 2026. Accessed March 24, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-chemotherapy-previously-untreated-hodgkin-lymphoma