On 1 June 2026, BMS announced that the European Commission has approved Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adults and adolescents over 12 years of age with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL). The Opdivo® plus AVD combination is the first immunotherapy-based regimen available in the EU for newly diagnosed advanced cHL.
This cHL indication was recommended by the CHMP in April 2026 and approved by the FDA in March 2026. BMS also added another cHL indication to its European registration in March 2026, with approval for nivolumab in combination with brentuximab vedotin for the treatment of relapsed or refractory cHL after one prior line of therapy.
A number of nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.