FDA Approves Nivolumab Combo as First-Line Hodgkin Lymphoma Treatment

The Food and Drug Administration approved a combination therapy of nivolumab and chemotherapy as a first-line treatment for adult and pediatric patients aged 12 years and older with stage III or IV classical Hodgkin lymphoma, the agency announced Friday.

The approval is based on data from a randomized trial demonstrating that the addition of nivolumab (Opdivo, Bristol Myers Squibb) to doxorubicin, vinblastine, and dacarbazine (AVD) resulted in a 58% improvement in progression-free survival compared to brentuximab vedotin (Adcetris, Seagen) plus AVD. According to the FDA, after a median follow-up of 13.7 months, the nivolumab arm showed a significantly reduced risk of progression or death (HR = 0.42. 95% CI, 0.27-0.67). At a median follow-up of 36.7 months, fewer deaths were reported in the nivolumab arm (1.8% vs. 3.4%).

Serious adverse reactions occurred in 39% of patients receiving nivolumab, with immune-mediated adverse events reported in 9% of patients, including 2.7% experiencing grade 3-4 events. The FDA-recommended dose for nivolumab is 240 mg intravenously for patients weighing at least 40 kg, and 3 mg/kg for those weighing less than 40 kg. Treatment is administered on days 1 and 15 of 28-day cycles for up to six cycles.

The FDA also granted traditional approval for nivolumab in patients following autologous hematopoietic stem cell transplant and brentuximab vedotin, as well as after three or more lines of systemic therapy, including at least one stem cell transplant. These indications had previously received accelerated approval.

The approval stems from the phase 3 SWOG S1826 trial, which enrolled 994 patients, as previously reported by Healio.

As of March 20, 2026, the FDA has not issued a statement regarding potential impacts on drug pricing or patient access following this approval.