On March 20, 2026, the U.S. Food and Drug Administration approved a new combination treatment for patients newly diagnosed with advanced Hodgkin lymphoma — and it marks a significant milestone: the first immunotherapy regimen ever approved for this patient population in the frontline setting.
The drug is nivolumab (Opdivo), a checkpoint inhibitor made by Bristol-Myers Squibb, and it will now be used alongside standard chemotherapy — a combination known as AVD (doxorubicin, vinblastine, and dacarbazine) — for adult and paediatric patients aged 12 and older with Stage III or IV classical Hodgkin lymphoma who have not yet received any treatment.
What the Trial Showed
The approval was based on results from the SWOG 1826 study, a randomised, open-label trial comparing nivolumab plus AVD against brentuximab vedotin plus AVD — the previous standard of care for newly diagnosed advanced Hodgkin lymphoma.
Nivolumab plus AVD showed superior progression-free survival, with a hazard ratio of 0.42 — meaning patients on the new regimen had roughly 58% less risk of their disease progressing or of death compared to those receiving the old standard treatment. That is a substantial clinical improvement.
What Hodgkin Lymphoma Is
Hodgkin lymphoma is a cancer of the lymphatic system — the network of tissues and organs that help rid the body of toxins and carry immune cells. It is one of the most common cancers in young adults aged 15 to 35, but also occurs in older adults.
The good news is that Hodgkin lymphoma is highly treatable. Most people with early-stage disease are cured with chemotherapy or radiation. But advanced-stage disease (Stage III or IV) has historically been more difficult to control long-term, and patients who relapse face tougher treatment paths.
The SWOG 1826 results suggest that adding nivolumab to first-line chemotherapy could help more patients achieve lasting remission from the start — potentially reducing the number who ever experience relapse.
How Nivolumab Works
Nivolumab is a PD-1 checkpoint inhibitor. It works by blocking a protein that tumour cells use to hide from the immune system, essentially removing the "cloak" that cancer uses to evade attack. Hodgkin lymphoma cells are known to heavily express PD-L1, the molecule that activates this hiding mechanism — which is why PD-1 inhibitors have shown particular promise against this cancer type.
Nivolumab was already approved for relapsed or refractory Hodgkin lymphoma. This new approval extends its use to patients who haven't been treated yet — earlier in the disease course, when outcomes can be influenced most significantly.
The FDA has also simultaneously converted Opdivo's previous accelerated approvals in relapsed/refractory Hodgkin lymphoma to regular approvals, reflecting the maturity and strength of the long-term data.
Sources: U.S. Food and Drug Administration · Bristol-Myers Squibb · OncLive · CancerNetwork · CureToday · SWOG 1826 trial data (March 20, 2026)
