The European Commission has approved Opdivo (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and adolescent patients aged 12 and older with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), making it the first immunotherapy-based regimen authorized in the EU for newly diagnosed advanced disease. The decision, announced June 1, 2026, expands the EU label for Bristol Myers Squibb’s (NYSE: BMY) PD-1 inhibitor into the frontline setting — a significant shift in how the disease may be managed across the bloc’s 27 member states, as well as Iceland, Liechtenstein, and Norway.
A new standard in frontline cHL
The approval follows a US FDA authorization granted in March 2026 for the same nivolumab-AVD combination in the identical population, consolidating the regimen’s position as the first checkpoint inhibitor-based option in first-line advanced cHL on both sides of the Atlantic.
Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, restoring T-cell-mediated antitumor activity. When added to the AVD chemotherapy backbone, the rationale is that immune checkpoint blockade may amplify the cytotoxic effect of chemotherapy in a tumor type known to exploit the PD-1 pathway for immune evasion.
SWOG 1826 trial data
The EC decision is grounded in data from the Phase III SWOG 1826 trial (NCT03907488; also known as CA2098UT), a randomized, multicenter study enrolling adult and pediatric patients aged 12 and older with previously untreated Stage III or IV cHL. The trial’s primary endpoint was progression-free survival (PFS).
At a median follow-up of 13.7 months, nivolumab plus AVD demonstrated a 58% reduction in the risk of disease progression or death compared with brentuximab vedotin plus AVD — the prior frontline standard — with a hazard ratio of 0.42 (95% CI: 0.27–0.67; P < 0.0001). After extended follow-up of 36.7 months, median overall survival had not been reached in either arm; there were 9 deaths (1.8%) in the nivolumab-AVD group versus 17 (3.4%) in the brentuximab vedotin-AVD group, representing 26 total deaths.
Serious adverse reactions occurred in 39% of patients receiving nivolumab plus AVD, with the most frequent including neutropenia (7%), pyrexia (7%), febrile neutropenia (6%), and nausea (6%). Three patients (0.6%) died from sepsis.