FDA Approves Nivolumab Addition to AVD Chemotherapy for Patients 12 and Older with Hodgkin Lymphoma
The U.S. Food and Drug Administration approved the addition of nivolumab (Opdivo) to AVD chemotherapy for patients aged 12 and older with previously untreated Stage III or IV classical Hodgkin lymphoma on March 20, 2026. The approval was based on a clinical trial showing that nivolumab plus AVD improved progression-free survival compared to brentuximab vedotin plus AVD, officials said.
The approval covers both adult and pediatric patients aged 12 years and older with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), according to the FDA announcement on March 20, 2026. Nivolumab, marketed as Opdivo by Bristol Myers Squibb, is administered intravenously on days 1 and 15 of each 28-day cycle alongside AVD chemotherapy, which consists of doxorubicin, vinblastine, and dacarbazine given for six cycles. Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) begins with the first cycle to reduce the risk of neutropenia, officials said.
Results showed that the nivolumab plus AVD regimen significantly improved PFS compared to brentuximab vedotin plus AVD, with a hazard ratio of 0.42 (95% confidence interval, 0.27 to 0.67; p<0.0001), according to the FDA’s review documents.
The FDA granted priority review and orphan drug designation to the combination under Project Orbis, an initiative for concurrent international regulatory collaboration, the agency added. The approval was based on data from Study CA209-8UT (SWOG 1826; NCT03907488), a randomized, open-label, multicenter trial enrolling 994 patients aged 12 and older with previously untreated Stage III or IV cHL. Patients were randomized in a 1:1 ratio to receive either nivolumab plus AVD or brentuximab vedotin plus AVD for six cycles.
The primary endpoint of the trial was progression-free survival (PFS) assessed by investigators. The three-year PFS rate was higher in the nivolumab-AVD arm, demonstrating superior efficacy in frontline treatment of advanced cHL. Fewer than 4% of patients in the nivolumab arm discontinued treatment due to adverse effects, records show.
Alex Herrera, M.D., chief of the Lymphoma Division at City of Hope, stated that the SWOG 1826 trial data supported the use of nivolumab plus AVD as a frontline immunotherapy-based regimen, improving outcomes compared to the previous standard of care involving brentuximab vedotin. Bristol Myers Squibb highlighted that these findings represent a transformation in the treatment paradigm for classical Hodgkin lymphoma.
Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that blocks signals preventing the immune system from attacking cancer cells. It had previously received accelerated approval from the FDA in 2016 and 2017 for relapsed or refractory cHL in patients after hematopoietic stem cell transplantation or brentuximab vedotin, or those who had received at least three prior lines of therapy. The March 2026 FDA actions converted these accelerated approvals to traditional approvals for the relapsed/refractory indications, according to the agency.
The full prescribing information for Opdivo was posted on the FDA’s Drugs@FDA database following the approval. For single-patient investigational new drug requests, the FDA directs clinicians to contact the Oncology Center of Excellence’s Project Facilitate at 240-402-0004 or via email at [email protected].
In addition to nivolumab’s approval, the FDA also approved other blood cancer treatments, including teclistamab plus daratumumab for multiple myeloma, officials noted. Bristol Myers Squibb’s press release confirmed expanded U.S. and European Medicines Agency approvals for Opdivo in combination with AVD chemotherapy for frontline treatment of advanced classical Hodgkin lymphoma.
The approval expands access to immunotherapy-based regimens in the frontline setting for this patient population, addressing challenges in treating newly diagnosed and relapsed classical Hodgkin lymphoma, according to the FDA and manufacturer statements.
