BMS secures FDA and EC approvals for Opdivo in Hodgkin Lymphoma

Back to news list

Source: Pharmaceutical Technology

Original: https://www.pharmaceutical-technology.com/news/bms-fda-ec-approvals-opdivo/...

Published: Mon, 23 Mar 2026 09:28:03 +0000

On March 20, 2026, the US FDA approved nivolumab (Opdivo from Bristol Myers Squibb) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) chemotherapy for adult and pediatric patients 12 years of age and older with untreated stage III or IV classical Hodgkin's lymphoma (cHL).[1][2][6] At the same time, the FDA granted traditional approval to nivolumab for adult patients with relapsed or refractory cHL after autologous stem cell transplantation (HSCT) and brentuximab vedotin or after three or more lines of systemic therapy including HSCT.[1][2] These indications for relapsed/refractory cHL received accelerated approval in 2016 and 2017.[1] The effectiveness of the combination of nivolumab + AVD was confirmed by the randomized study CA209-8UT (SWOG 1826; NCT03907488) with 994 patients from 12 years of age with untreated cHL stage III/IV, where 6 cycles of treatment were administered.[1][2] In the nivolumab + AVD arm, serious adverse reactions occurred in 39% of patients and immune-mediated reactions in 9% (including grade 3-4 in 2.7%).[1] The recommended dose is 240 mg intravenously (for adults and children ≥40 kg) or 3 mg/kg (for children <40 kg) on ​​days 1 and 15 of each 28-day cycle for up to 6 cycles, with G-CSF prophylaxis from the first cycle.[1] EC approval for Opdivo in Hodgkin's lymphoma expands its use to both pediatric and adult patients.[5]