FDA Greenlights Nivolumab Plus AVD Regimen for Untreated Classic Hodgkin Lymphoma in March

The U.S. Food and Drug Administration approved nivolumab (Opdivo) in combination with AVD chemotherapy on March 20, 2026, for treating adult and pediatric patients aged 12 and older with previously untreated Stage III or IV classical Hodgkin lymphoma. The approval was based on a clinical trial showing that the nivolumab-AVD regimen significantly improved progression-free survival compared to brentuximab vedotin plus AVD, officials said.

The FDA’s approval of nivolumab (Opdivo) combined with AVD chemotherapy (doxorubicin, vinblastine, dacarbazine) applies to both adult and pediatric patients aged 12 years and older with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), according to the agency’s March 20, 2026, announcement. The decision was based on data from the randomized, open-label multicenter trial CA209-8UT (SWOG 1826; NCT03907488), which enrolled 994 patients across multiple sites, officials said.

Results demonstrated a statistically significant improvement in PFS for the nivolumab-AVD arm, with a hazard ratio of 0.42 (95% confidence interval [CI], 0.27 to 0.67; p<0.0001), according to FDA records.

In the trial, patients were randomized in a 1:1 ratio to receive either nivolumab plus AVD or brentuximab vedotin plus AVD for six cycles. The primary endpoint was progression-free survival (PFS) assessed by investigators. At a median follow-up of 12.1 months, the hazard ratio remained favorable at 0.48 (99% CI, 0.27 to 0.87; p=0.001), sources confirmed.

Follow-up data at three years further supported the superiority of nivolumab in combination with AVD over the brentuximab vedotin-AVD regimen, as reported in a 2025 publication in Blood (146[suppl 1]:151). The study’s findings underpinned the regulatory decision for this new first-line treatment option in advanced-stage cHL, the FDA said.

Nivolumab, developed and manufactured by Bristol Myers Squibb Company, had previously received traditional approval for adults with relapsed or refractory classical Hodgkin lymphoma following hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after three or more prior lines of therapy. The March 2026 approval expands its indication to untreated patients with advanced disease, officials noted.

The FDA review process utilized a Summary Review with Assessment Aid submitted by Bristol Myers Squibb. The nivolumab-AVD combination underwent priority review starting in December 2025, expediting the evaluation timeline. The agency issued a news release on the day of approval, confirming the new indication. Full prescribing information is available through the Drugs@FDA database.

The trial enrolled patients aged 12 years and older, encompassing both pediatric and adult populations, with a diagnosis of classical Hodgkin lymphoma at stages III or IV who had not received prior therapy. The regimen excludes patients with earlier-stage disease or those previously treated. The study’s design and outcomes reflect an effort to improve frontline treatment for this subgroup, officials said.

In a corporate press release dated March 2026, Bristol Myers Squibb highlighted that the approval represented an expansion of nivolumab’s use in the U.S. and European markets. The company noted that the combination with AVD chemotherapy could shift the treatment paradigm for classical Hodgkin lymphoma, according to the statement. The European Commission has separately approved nivolumab in combination with brentuximab vedotin for patients aged 5 to 30 years with relapsed or refractory cHL after one prior therapy, based on phase II CheckMate 744 trial results.

Lymphoma advocacy groups and professional organizations reported the FDA’s March 20 approval alongside other regulatory actions involving blood cancer therapies. The SWOG S1826 trial that formed the basis for the approval is also summarized on the Lymphoma Hub platform, providing additional clinical context.

This expanded indication for nivolumab marks a significant regulatory milestone following earlier accelerated approvals that were converted to traditional status for relapsed disease settings in 2016 and 2017. The FDA’s decision may influence treatment guidelines and access for patients with advanced classical Hodgkin lymphoma, according to oncology sources.