FDA Grants Priority Review to Nivolumab-AVD in Classical Hodgkin Lymphoma

The FDA has accepted for priority review the supplemental biologics license application (sBLA) for nivolumab (Opdivo) in combination with doxorubicin (Adriamycin), vinblastine, and dacarbazine (AVD) for the treatment of adult and pediatric patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma (cHL).¹

The FDA anticipates a final regulatory decision by the Prescription Drug User Fee Act target date of April 8, 2026. This application represents a significant regulatory step toward establishing a checkpoint inhibitor-based regimen as a potential new frontline standard of care in advanced cHL.

“The FDA’s acceptance of our [sBLA] for priority review marks a pivotal milestone as we aim to bring a new and much-needed first-line option to adolescents and adults newly diagnosed with advanced-stage classical Hodgkin lymphoma,” said Monica Shaw, senior vice president, Oncology Commercialization, Bristol Myers Squibb, in a news release. “Hodgkin lymphoma remains a challenging disease, with an ongoing need for therapies that may deliver meaningful and durable outcomes early in a patient’s treatment journey.”

The submission is based on data derived from the phase 3 SWOG S1826/CA2098UT (NCT03907488) study, a randomized, open-label, multicenter trial sponsored by the National Cancer Institute through the National Clinical Trials Network (NCTN). The trial compared the efficacy and safety of nivolumab combined with AVD (N-AVD) against brentuximab vedotin (Adcetris) combined with AVD (BV-AVD) in the newly diagnosed advanced-stage cHL population.

In the pivotal findings from the interim analysis, N-AVD demonstrated superior progression-free survival (PFS) compared with BV-AVD with a median follow-up of 12.1 months (HR, 0.48; 99% CI, 0.27–0.87; 1-sided P =.0005). The estimated 1-year PFS rates were 94% for the N-AVD group vs 86% for the BV-AVD group. Extended follow-up data has continued to support this differential, with the 2-year PFS reaching 92% for N-AVD compared with 83% for BV-AVD (HR, 0.45; 95% CI, 0.30–0.65).²

The incorporation of nivolumab into the frontline setting addresses critical clinical needs within the Hodgkin lymphoma treatment paradigm. For decades, the standard-of-care regimen for advanced cHL was doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). While highly effective, ABVD carries a known risk of bleomycin-induced pulmonary toxicity. In recent years, BV-AVD demonstrated improved PFS over ABVD but introduced specific toxicities, notably increased rates of peripheral neuropathy and neutropenia.

The SWOG S1826 results indicate that the N-AVD regimen may offer a favorable toxicity profile compared to BV-AVD, specifically reporting significantly lower rates of sensory peripheral neuropathy in the nivolumab arm (28.1% vs 54.2% any grade). Although the rate of grade 3 or higher hematologic adverse events was numerically higher with N-AVD (48.4% vs 30.5%), rates of febrile neutropenia were similar between the arms. Importantly, fewer deaths due to adverse events were reported in the nivolumab cohort. The trial also observed a low rate of consolidating radiation therapy (RT) use across both arms, suggesting effective disease control without the need for additional local intervention.

Nivolumab is already approved for use in patients with cHL that has relapsed or progressed after autologous hematopoietic stem cell transplantation and brentuximab vedotin.¹

The SWOG S1826 trial is notable for its cooperative structure, representing the largest advanced-stage cHL study conducted within the NCTN and marking a successful collaboration between adult and pediatric cooperative groups, including the Children’s Oncology Group. The trial's findings hold particular relevance for pediatric and young adult oncology, where balancing cure rates with minimizing long-term treatment-related toxicities, such as secondary malignancies and cardiopulmonary damage, is paramount.

REFERENCES

1. 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 December 11, 2025. https://tinyurl.com/3beyhywv

2. Herrera A, LeBlanc M, Castellino S, et al. Nivolumab-AVD improves progression-free survival (PFS) compared to brentuximab vedotin-AVD in advanced stage (AS) classic Hodgkin lymphoma (HL), results of SWOG S1826. N Engl J Med. 2024 Oct 17;391(16):1559–1570.