FDA Approves Nivolumab Plus Doxorubicin, Vinblastine, and Dacarbazine for Previously Untreated Patients With Advanced Classical Hodgkin Lymphoma

Key Clinical Summary:

• The FDA has approved nivolumab plus doxorubicin, vinblastine, and dacarbazine for previously untreated patients aged ≥12 years with stage 3/4 classical Hodgkin lymphoma based on the phase 3 SWOG 1826 trial.  
• Progression-free survival was significantly improved with nivolumab plus doxorubicin, vinblastine, and dacarbazine with median progression-free survival not reached. At 36.7 months follow-up, mortality was lower with nivolumab plus doxorubicin, vinblastine, and dacarbazine. Serious adverse events occurred in 39%, with immune-related adverse events in 9%.
• Nivolumab plus doxorubicin, vinblastine, and dacarbazine establishes a new frontline standard of care for advanced Hodgkin lymphoma, delivering superior disease control with manageable immune-related toxicity compared with brentuximab-based therapy, and supporting broader integration of checkpoint inhibition in first-line treatment.

On March 20, 2026, the US Food and Drug Administration (FDA) approved nivolumab plus doxorubicin, vinblastine, and dacarbazine for adult and pediatric patients aged 12 years and older with previously untreated, advanced classical Hodgkin lymphoma based on results from the SWOG 1826 trial.

In this multicenter, open-label study, 994 patients with stage 3/4 classical Hodgkin lymphoma were randomized 1:1 to receive either nivolumab or brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine for up to 6 cycles. The primary end point was investigator-assessed progression-free survival (PFS). 

At a median follow-up of 13.7 months, median PFS was not reached in either treatment arm (hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.27 to 0.67; P < 0.0001). Serious adverse events were reported in 39% of patients receiving nivolumab plus doxorubicin, vinblastine, and dacarbazine. Any-grade immune-mediated adverse reactions were reported in 9% of patients and grade 3/4 immune-mediated reactions were reported in 2.7% of patients. 

At a median follow-up of 36.7 months, 1.8% of patients had died in the nivolumab plus doxorubicin, vinblastine, and dacarbazine arm and 3.4% of patients had died in the brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine arm. 

The recommended nivolumab dosage is 240 mg for adults and pediatric patients weighing ≥40 kg and 3 mg/kg for pediatric patients weighing <40 kg, administered intravenously on days 1 and 15 of each 28-day cycle in combination with doxorubicin, vinblastine, and dacarbazine for up to 6 cycles. The FDA recommends administration of primary G-CSF prophylaxis beginning in cycle 1.

The FDA has also approved nivolumab for previously approved indications in adult patients with relapsed or refractory Hodgkin lymphoma, including use after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or after 3 or more lines of systemic therapy, including autologous HSCT. These indications were previously granted accelerated approval in 2016 and 2017.

Source:

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