News|Articles|March 20, 2026

FDA Approves Opdivo Combo for Newly Diagnosed Advanced Hodgkin Lymphoma

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Key Takeaways

Frontline nivolumab plus AVD reduced risk of progression or death by 58% versus brentuximab vedotin plus AVD (PFS HR, 0.42) in advanced-stage classical Hodgkin lymphoma.
CA209-8UT randomized 994 patients (≥12 years) to six cycles of nivolumab+AVD or brentuximab vedotin+AVD, using investigator-assessed PFS as the primary endpoint.
Longer follow-up (median 36.7 months) showed deaths in 1.8% with nivolumab+AVD versus 3.4% with brentuximab vedotin+AVD, supporting a favorable survival signal.
Relapsed/refractory adult indications received traditional approval post–ASCT plus brentuximab vedotin, or after ≥3 prior systemic lines including transplant, converting 2016–2017 accelerated approvals.
Safety included serious AEs in 39% and immune-mediated AEs in 9% (grade 3/4: 2.7%); primary G-CSF prophylaxis is recommended starting cycle 1.

FDA approves Opdivo with AVD for stage 3 or 4 Hodgkin lymphoma after trial shows improved progression-free survival versus comparator in untreated patients.

The Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated stage 3 or 4 classical Hodgkin lymphoma, offering a new first-line treatment option based on improved progression-free survival. The agency also granted traditional approval to Opdivo for certain adults with relapsed or refractory disease, converting earlier accelerated approvals.

Main data that support the approval of Opdivo plus AVD

The approval was supported by results from a randomized clinical trial evaluating Opdivo plus AVD compared with brentuximab vedotin plus AVD in patients with newly diagnosed stage 3 or 4 classical Hodgkin lymphoma. The study showed that the Opdivo-based combination improved progression-free survival, meaning patients lived longer without their cancer growing or spreading.

Specifically, the hazard ratio for progression-free survival was 0.42, indicating a 58% reduction in the risk of disease progression or death with Opdivo plus AVD compared with the brentuximab vedotin regimen. At the time of analysis, the median progression-free survival had not been reached in either treatment group after a median follow-up of 13.7 months.

Longer-term follow-up also showed differences in survival outcomes. After a median follow-up of 36.7 months, 1.8% of patients in the Opdivo plus AVD group had died compared with 3.4% in the brentuximab vedotin plus AVD group. These findings supported the FDA’s decision to approve the regimen as an initial treatment for patients with advanced disease.

In addition to this frontline approval, the FDA granted traditional approval to Opdivo for adults with relapsed or refractory classical Hodgkin lymphoma who previously received an autologous hematopoietic stem cell transplant and brentuximab vedotin, or who have received three or more prior lines of systemic therapy that included a stem cell transplant. These indications had previously received accelerated approval in 2016 and 2017.

Trial details of CA209-8UT

The findings came from Study CA209-8UT, a randomized, open-label, multicenter trial that enrolled patients 12 years and older with previously untreated stage 3 or 4 classical Hodgkin lymphoma. A total of 994 patients were randomly assigned in a 1 to 1 ratio to receive either Opdivo plus AVD or brentuximab vedotin plus AVD.

Patients in both groups received treatment for up to six cycles. The primary endpoint of the study was progression-free survival as assessed by investigators.

For patients receiving the newly approved regimen, the recommended dose of Opdivo is 240 milligrams (mg) for adults and pediatric patients weighing at least 40 kilogram (kg), or 3 mg per kg for pediatric patients weighing less than 40 kg. The drug is given intravenously on days 1 and 15 of each 28-day cycle in combination with AVD for up to six cycles. The use of primary G-CSF prophylaxis is recommended starting in the first cycle to help support white blood cell counts during treatment.

The FDA review was conducted under Project Orbis, an initiative that allows for concurrent review of cancer treatments among international regulatory agencies.

The application also received priority review and orphan drug designation, both of which are part of FDA programs designed to speed the development and review of treatments for serious conditions.

Safety of Opdivo plus AVD

In the Opdivo plus AVD treatment group, serious side effects occurred in 39% of patients. Immune-mediated side effects, which are linked to how the drug affects the immune system, occurred in 9% of patients, with 2.7% experiencing grade 3 (severe) or 4 (life-threatening) events.

These findings reflect the known safety profile of Opdivo and highlight the importance of monitoring for immune-related side effects during treatment. Patients receiving this regimen should be closely followed by their care team to manage potential side effects.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.