FDA Approves Nivolumab Plus Doxorubicin, Vinblastine, and Dacarbazine for Advanced Classical Hodgkin Lymphoma
Clinical Summary:
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The FDA approved nivolumab plus doxorubicin, vinblastine, and dacarbazine for adult and pediatric patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma based on findings from the phase 3 SWOG 1826 trial.
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Nivolumab plus doxorubicin, vinblastine, and dacarbazine significantly improved progression-free survival compared with brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine, with median progression-free survival not reached in either arm at the primary analysis. With 36.7 months of follow-up, fewer deaths had occurred in the nivolumab arm, while immune-mediated adverse events remained infrequent and manageable.
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This approval establishes a chemotherapy plus PD-1 inhibitor regimen as a first-line treatment option for advanced classical Hodgkin lymphoma, offering improved disease control with a manageable safety profile.
On March 20, 2026, the US Food and Drug Administration (FDA) approved nivolumab in combination with doxorubicin, vinblastine, and dacarbazine for adult and pediatric patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma. The approval was supported by findings from the phase 3 SWOG 1826 trial.
In this multicenter, open-label trial, 994 patients with stage III or IV classical Hodgkin lymphoma were randomized 1:1 to receive nivolumab plus doxorubicin, vinblastine, and dacarbazine or brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine for up to 6 treatment cycles. The primary end point was investigator-assessed progression-free survival (PFS).
At the primary analysis, median PFS was not reached in either treatment arm. Nivolumab plus doxorubicin, vinblastine, and dacarbazine significantly reduced the risk of disease progression or death compared with brentuximab vedotin plus AVD (hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.27 to 0.67; P < .0001).
With extended follow-up of 36.7 months, 1.8% of patients receiving nivolumab plus doxorubicin, vinblastine, and dacarbazine had died compared with 3.4% of those treated with brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine.
Serious adverse events occurred in 39% of patients receiving nivolumab plus doxorubicin, vinblastine, and dacarbazine. Immune-mediated adverse reactions of any grade were reported in 9% of patients, with grade 3 or 4 immune-mediated adverse reactions occurring in 2.7%.
The recommended nivolumab dose is 240 mg intravenously for adults and pediatric patients weighing at least 40 kg, or 3 mg/kg for pediatric patients weighing less than 40 kg, administered on days 1 and 15 of each 28-day cycle in combination with doxorubicin, vinblastine, and dacarbazine for up to 6 cycles. Primary granulocyte colony-stimulating factor prophylaxis is recommended beginning with cycle 1.
The FDA also converted the accelerated approvals of nivolumab monotherapy to traditional approval for adults with relapsed or refractory classical Hodgkin lymphoma following autologous hematopoietic stem cell transplantation and brentuximab vedotin, or after at least three prior lines of systemic therapy, including autologous transplantation.
Source:
US Food and Drug Administration. FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma. Accessed on March 20, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-chemotherapy-previously-untreated-hodgkin-lymphoma
