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FDA and EC approve nivolumab combination therapies for cHL
On March 20, 2026, the U.S. Food and Drug Administration (FDA) approved nivolumab, in combination with doxorubicin + vinblastine + dacarbazine (AVD), for the treatment of patients aged ≥12 years with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL).1 The European Commission (EC) also approved nivolumab, in combination with brentuximab vedotin (BV), for the treatment of patients aged 5–30 years with relapsed/refractory (R/R) cHL after one prior line of therapy.1
The FDA approval is based on results from the phase III SWOG S1826 (NCT03907488) study, which compared nivolumab + AVD to BV + AVD in 994 patients aged ≥12 years with previously untreated Stage III or IV cHL.1,2 Results from the SWOG 1826 trial have previously been published on the Lymphoma Hub. At a median follow-up of 12.1 months, nivolumab + AVD significantly improved progression-free survival (PFS) vs BV+AVD (hazard ratio [HR], 0.48; 99% confidence interval [CI], 0.27–0.87; p = 0.001). The most common serious adverse events (AEs) in patients receiving nivolumab + AVD were peripheral neuropathy (41%), neutropenia (7%), pyrexia (7%), febrile neutropenia (6%), and nausea (6%).1 An approval submission based on results from SWOG 1826 is also under evaluation by the European Medicines Agency (EMA).
The EC approval is based on results from the phase II CheckMate 744 (NCT02927769) study, evaluating nivolumab + BV, followed by BV + bendamustine for patients with a suboptimal response, in patients aged 5–30 years with R/R cHL after one prior line of therapy.1 The complete metabolic response rate, per blinded independent central review, was 59% after four cycles of induction with nivolumab + BV, 82% after two cycles of intensification with BV + bendamustine, and 94% at any time before consolidation, with an overall response rate of 100%.3 Treatment-related AEs (TRAEs) occurred in 70% of patients during nivolumab + BV induction, with Grade ≥3 TRAEs in 18% of patients.3 The most common TRAEs of any grade were hypersensitivity (20%), nausea (20%), and diarrhea (14%).3
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