FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma

FDA action (regulatory approval)

On March 20, 2026, the FDA granted accelerated approval to nivolumab (Opdivo) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for adults and pediatric patients aged ≥12 years with previously untreated stage III or IV classical Hodgkin lymphoma (cHL).

The FDA also granted traditional approval to nivolumab in adults with relapsed/refractory cHL: (1) after autologous HSCT and brentuximab vedotin, and (2) after ≥3 lines of systemic therapy including autologous HSCT. These relapsed/refractory indications had received accelerated approvals in 2016 and 2017, respectively.

Supporting evidence

Efficacy and safety were evaluated in Study CA209-8UT (SWOG 1826; NCT03907488), a randomized, open-label, multicenter trial in patients ≥12 years with previously untreated stage III–IV cHL. 994 patients were randomized 1:1 to nivolumab+AVD or brentuximab vedotin+AVD for 6 cycles.

Primary endpoint was investigator-assessed PFS. Nivolumab+AVD improved PFS vs comparator (HR 0.42; 95% CI 0.27–0.67; p<0.0001). Median PFS was not reached in either arm at 13.7 months median follow-up. At 36.7 months median follow-up, deaths were 1.8% vs 3.4%, respectively.

Safety and dosing (per FDA summary)

In the nivolumab+AVD arm, serious adverse reactions occurred in 39%; immune-mediated adverse reactions occurred in 9% (Grade 3–4: 2.7%). Recommended nivolumab dosing: 240 mg (adults and pediatrics ≥40 kg) or 3 mg/kg (<40 kg) IV on Days 1 and 15 of each 28-day cycle for up to 6 cycles; primary G-CSF prophylaxis is recommended starting cycle 1.

Review occurred under Project Orbis; partner agencies may still be reviewing the application.