Nivolumab/AVD Receives FDA Priority Review in Classical Hodgkin Lymphoma

The FDA has accepted and granted priority review to a supplemental biologics license application for nivolumab (Opdivo) plus doxorubicin, vinblastine, and dacarbazine (AVD) for patients 12 years and older who have previously untreated stage III or IV classical Hodgkin lymphoma, according to a press release from Bristol Myers Squibb.¹

The Prescription Drug User Fee Act date is set for April 8, 2026.

This decision was based on results from the phase 3 SWOG S1826 (CA2098UT) trial (NCT03907488). Updated results regarding the 3-year follow-up of the progression-free survival (PFS) were presented at the 2025 American Society of Hematology (ASH) Annual Meeting and Exposition.²

“The FDA’s acceptance of our supplemental biologics license application 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,” Monica Shaw, senior vice president, Oncology Commercialization, Bristol Myers Squibb, said in the press release.¹ “[Nivolumab] in combination with AVD represents a potential new standard of care in the frontline treatment of advanced [classical Hodgkin lymphoma] for adolescents and adults. 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. We look forward to collaborating with the FDA throughout the review process to bring this important option to patients as quickly as possible.”

A total of 994 patients were randomly assigned 1:1 to receive either nivolumab at 240 mg plus AVD on days 1 and 15 for 6 cycles (n = 470) or brentuximab vedotin (Adcetris) at 1.2 mg/kg plus AVD on days 1 and 15 for 6 cycles (n = 470).

After 3 years of follow-up, the PFS rate was 91% (95% CI, 88%-93%) in the nivolumab plus AVD arm vs 82% (95% CI, 78%-85%) in the brentuximab vedotin plus AVD arm (P <.0001). For the adolescent population, the PFS rate was 93% (95% CI, 87%-96%) in the nivolumab arm vs 82% (95% CI, 73%-88%) in the brentuximab vedotin arm, with a stratified log-rank P value of .004.

For patients with an international prognostic score (IPS) of 0 to 3, the 3-year PFS estimate was 84% (95% CI, 80%-88%) in the brentuximab vedotin arm vs 92% (95% CI, 88%-95%) in the nivolumab arm (HR, 0.45; 95% CI, 0.28-0.72). For those with an IPS of 4 to 7, the 3-year estimated PFS was 77% (95% CI, 69%-83%) vs 87% (95% CI, 81%-92%) in each arm (HR, 0.57; 95% CI, 0.33-0.97).

An estimated 3-year event-free survival (EFS) benefit was noted with 80% (95% CI, 76%-83%) in the brentuximab vedotin arm vs 87% (95% CI, 84%-90%) in the nivolumab arm (HR, 0.56; 95% CI, 0.41-0.78). Types of EFS events in the nivolumab and brentuximab vedotin arms, respectively, included non-protocol chemotherapy prior to progressive disease (2.7% vs 1.4%), non-protocol radiation therapy prior to progressive disease (0.6% vs 1.0%), progression or relapse (8.2% vs 14.9%), death without progression (1.2% vs 2.7%), and total EFS events (12.7% vs 20.0%).

The 3-year estimated overall survival (OS) in the brentuximab vedotin arm was 97% (95% CI, 95%-98%) vs 98% (95% CI, 97%-99%) in the nivolumab arm (HR, 0.48; 95% CI, 0.20-1.15). Cause of death between each arm included infection/sepsis (n = 6 vs 5), lymphoma (n = 2 vs 1), medical issue or other cancer (n = 4 vs 2), new primary cancer (n = 1 vs 0), and unknown (n = 2 vs 0).

In the nivolumab arm, 1.2% of patients had secondary cancers at the 3-year follow-up vs 2.3% in the brentuximab vedotin arm. These included non-Hodgkin lymphoma (n = 4 vs 3), skin cancer (n = 1 vs 0), multiple myeloma (n = 0 vs 1), and solid tumors (n = 1 vs 7).

“These data support [nivolumab] plus AVD as a standard regimen for advanced stage classical Hodgkin lymphoma,” presenting author Alex F. Herrera, MD, chief and professor in the Division of Lymphoma of the Department of Hematology and Hematopoietic Cell Transplantation, and associate medical director of the Briskin Center for Clinical Research at City of Hope, stated at ASH. “[Additionally, this regimen] is a NCCN guidelines category 1 recommendation.”

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/ru8e426u
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