Immune Checkpoint Inhibitor Nivolumab Approved for Untreated Advanced Classical Hodgkin Lymphoma

Simultaneously, previous accelerated approvals for nivolumab in relapsed/refractory advanced classical Hodgkin lymphoma were converted to full approvals.

The U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with the chemotherapy regimen doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients aged 12 and older with previously untreated, stage 3 or 4 classical Hodgkin lymphoma.

Concurrent with this approval, the FDA converted two accelerated approvals for nivolumab to traditional approvals:

  • Nivolumab was granted traditional approval for adults with relapsed or refractory classic Hodgkin lymphoma that has progressed after autologous hematopoietic stem cell transplant (HSCT) and posttransplant brentuximab vedotin (Adcetris). This indication had received accelerated approval in 2016.
  • Nivolumab was granted traditional approval for adults with relapsed or refractory classic Hodgkin lymphoma that has progressed after at least three lines of systemic therapy that includes autologous HSCT. This indication had received accelerated approval in 2017.
Immune checkpoint inhibitors, like nivolumab, help prevent suppression of the antitumor immune response.

Nivolumab is a PD-1-targeted immune checkpoint inhibitor, a type of immunotherapy that can reverse suppression of antitumor immune responses, and this approval is the first immunotherapy-based combination approved as a first-line treatment for advanced classical Hodgkin lymphoma. The conversion of the two accelerated approvals into full approvals resulted from clinical trial results that confirmed clinical benefits in line with the early results observed at the point of accelerated approval. Nivolumab is now another PD-1-targeted therapy with full approval to treat relapsed or refractory classical Hodgkin lymphoma, alongside the immune checkpoint inhibitor pembrolizumab (Keytruda).

The approval of nivolumab and AVD for untreated classical Hodgkin lymphoma was based on Study CA209-8UT (SWOG S1826), a randomized, open-label, multicenter phase III trial that enrolled 994 patients who were at least 12 years old and had previously untreated, stage 3 or 4 classical Hodgkin lymphoma. Patients were randomly assigned 1:1 to receive either nivolumab plus AVD or brentuximab vedotin plus AVD for six cycles.

After a median follow-up of 13.7 months, patients receiving nivolumab with AVD were 58% less likely to experience disease progression or death than the patients receiving brentuximab vedotin with AVD. In both arms, fewer than half of the patients had experienced disease progression by the time of follow-up. After a median follow-up period of 36.7 months, the fatality rate in the nivolumab and AVD arm was lower at 1.8% than the fatality rate in the brentuximab and AVD arm at 3.4%.

The recommended dosage of nivolumab is based on body weight: 240 mg (for adults and pediatric patients weighing 40 kg or more), or 3 mg/kg (for pediatric patients weighing less than 40 kg). Nivolumab should be administered intravenously every two weeks with AVD for six cycles, and the chemotherapy agents should be administered before nivolumab. Administration of primary granulocyte colony-stimulating factor (a neutropenia preventive) is recommended starting with the first cycle.

Classical Hodgkin lymphoma is the most common type of Hodgkin lymphoma, a cancer of the lymphatic system. According to federal statistics, it was estimated that 8,720 individuals would be diagnosed with Hodgkin lymphoma and 1,150 patients would die of the disease in the United States in 2025.

The FDA rendered its decision on March 20, 2026. Check this resource for updated information on all therapeutics regulated by the FDA.