Overview
- The approval covers patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma.
- In the SWOG S1826/CA209-8UT trial of 994 patients, nivolumab plus AVD reduced the risk of progression or death versus brentuximab vedotin plus AVD (HR 0.42) at 13.7 months’ median follow-up.
- Longer follow-up showed numerically fewer deaths with the nivolumab regimen at 36.7 months (1.8% vs 3.4%).
- The FDA-recommended dosing is 240 mg IV for patients weighing at least 40 kg or 3 mg/kg for those under 40 kg on days 1 and 15 of 28-day cycles for up to six cycles, with primary G-CSF prophylaxis starting in cycle 1.
- Safety findings included serious adverse reactions in 39% and immune-mediated events in 9% of patients receiving nivolumab plus AVD, with 2.7% grade 3–4 events.