FDA Grants Priority Review for Opdivo Combo in Advanced Lymphoma

The U.S. Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for Opdivo (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD), a kind of chemotherapy, for adults and pediatric patients aged 12 years and older with previously untreated stage 3 or 4 classical Hodgkin lymphoma (cHL), according to a news release from Bristol Myers Squibb.

The FDA has set a target action date of April 8, 2026, under the prescription drug user fee act (PDUFA), meaning the FDA aims to complete its review of the application and decide on approval by that date.

“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 of Oncology Commercialization at Bristol Myers Squibb. “Opdivo in combination with AVD represents a potential new standard of care in the frontline treatment of advanced cHL 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.”

What Information Supported the FDA Review of Opdivo and Chemo in this Patient Population?

The priority review is based on results from the phase 3 SWOG S1826 (also known as CA2098UT) study, a randomized, multicenter trial evaluating Opdivo in combination with AVD for both adult and pediatric patients 12 years and older with previously untreated stage 3 o r4 cHL. The study’s primary goal is to assess progression-free survival, with secondary end points including overall survival and other measures of treatment efficacy and safety.

Sponsored by the National Cancer Institute (NCI) in collaboration with Bristol Myers Squibb, SWOG S1826 is the largest cHL study conducted in the NCI National Clinical Trials Network.

Understanding Classical Hodgkin Lymphoma

Hodgkin lymphoma is a cancer that begins in white blood cells called lymphocytes, which are critical components of the immune system. Adolescents, particularly those aged 15 to 19, are the most commonly diagnosed, with peaks also seen in early adulthood (between the ages of 20 and 39 years) and later adulthood (over 55 years). cHL accounts for approximately 95% of all Hodgkin lymphoma cases, and despite advancements in frontline therapy, patients with advanced-stage disease face a considerable risk of relapse.

Overall, according to the news release, these aspects emphasize the need for innovative treatments that can provide long-lasting remission while minimizing treatment-related burden.

Opdivo’s Mechanism and Role in Cancer Therapy

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to harness the body’s immune system to recognize and attack cancer cells. The therapy has become a key treatment option across multiple cancer types, including melanoma, non-small cell lung cancer, renal cell carcinoma, urothelial carcinoma, and others. Since its first regulatory approval in 2014, Opdivo has been approved in more than 65 countries, the news release emphasizes.

For Hodgkin lymphoma specifically, Opdivo is currently approved for adults with cHL that has relapsed or progressed following autologous hematopoietic stem cell transplantation and Adcetris (brentuximab vedotin) or after three or more lines of systemic therapy. The current FDA review seeks to extend its use to first-line therapy in combination with AVD.

The Impact of Potential FDA Approval for Opdivo and Chemo in cHL

Bristol Myers Squibb expressed commitment to working closely with the FDA throughout the review process to make this therapy available to patients as efficiently as possible. The SWOG S1826 study represents an important effort to expand understanding of how immunotherapy can be integrated into frontline care for cHL.

Reference

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, by Bristol Myers Squibb. News release; Dec. 11, 2025.

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