FDA Approves Nivolumab/AVD in Untreated Hodgkin Lymphoma

The FDA has approved a combination of nivolumab (Opdivo) plus the chemotherapy triplet of doxorubicin, vinblastine, and dacarbazine (AVD), for the treatment of patients 12 years and older with previously untreated, stage III or IV classical Hodgkin lymphoma, according to a news release from the agency.¹

Moreover, approval has been granted to nivolumab as a treatment for adult patients with relapsed/refractory classical Hodgkin lymphoma, specifically following autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin (Adcetris) or following 3 or more lines of systemic therapy including autologous HSCT.

Supporting the regulatory decision were findings from the phase 3 SWOG 1826/CA209-8UT trial (NCT03907488), which examined the nivolumab-based regimen vs a brentuximab vedotin-based regimen, both with AVD, in this classical Hodgkin lymphoma population.²

The progression-free survival (PFS) per investigator assessment was found to be superior with the nivolumab arm (HR, 0.42; 95% CI, 0.27-0.67; P <.0001). Additionally, the median PFS was not reached in either arm after a median follow-up of 13.7 months. Moreover, 1.8% and 3.4% of patients in the nivolumab and brentuximab vedotin arms died after a median follow-up of 36.7 months.

Serious adverse reactions were observed in 39% of the niviolumab arm, with 9% of patients experiencing immune-mediated reactions, including 2.7% at grade 3 or 4.

The recommended dose for nivolumab is 240 mg among adults and pediatric patients weighting at least 40 kg; the dose is 3 mg/kg for pediatric patients weighing less. Nivolumab is given via intravenous infusion in combination with AVD on days 1 and 15 of each 28-day cycle for a maximum of 6 cycles. Starting cycle 1, primary G-CSF prophaylaxis is recommended.

The nivolumab/AVD regimen previously received FDA priority review in classical Hodgkin lymphoma in December 2025.³

References

1. FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma. News release. FDA. March 20, 2026. Accessed March 20, 2026. https://tinyurl.com/4dxanszv
2. Herrera A, Leblanc M, Castellino S, et al, 3-year follow-up of the S1826 study confirms improved progression-free survival with nivolumab-AVD compared to brentuximab vedotin-AVD in advanced stage classic Hodgkin lymphoma. Blood. 2025;146(suppl 1):151. doi.10.1182/blood-2025-151
3. U.S. Food and Drug Administration (FDA) grants priority review to Bristol Myers Squibb's Application for Opdivo® (nivolumab) plus chemotherapy combination for classical Hodgkin lymphoma. News release. Bristol Myers Squibb. December 11, 2025. Accessed March 20, 2026. https://tinyurl.com/ru8e426u