On March 20, 2026, the Food and Drug Administration approved nivolumab with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and paediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). The FDA also granted traditional approval to nivolumab for the following indications in adults with relapsed or refractory cHL:

• after autologous haematopoietic stem cell transplantation (HSCT) and brentuximab vedotin
• after three or more lines of systemic therapy that includes autologous HSCT.
• Nivolumab received accelerated approval for these indications in 2016 and 2017, respectively.

Full prescribing information for nivolumab will be posted on Drugs@FDA. 

Efficacy and Safety

Efficacy of nivolumab in combination with AVD was evaluated in Study CA209-8UT (SWOG 1826; NCT03907488), a randomised, open-label, multicenter trial in patients 12 years and older with previously untreated, Stage III and IV cHL. A total of 994 patients were randomised (1:1) to receive either nivolumab plus AVD or brentuximab vedotin plus AVD for 6 cycles.

The primary efficacy outcome measure was progression-free survival (PFS) per investigator. The study demonstrated superiority of PFS in the nivolumab plus AVD arm, with a hazard ratio of 0.42 (95% CI: 0.27, 0.67; p-value <0.0001). The median PFS was not reached in either arm, after a median follow-up of 13.7 months. After a median follow-up of 36.7 months, there were 1.8% deaths in the nivolumab plus AVD arm and 3.4% in the brentuximab vedotin plus AVD arm.

In the nivolumab plus AVD arm, serious adverse reactions occurred in 39% and immune-mediated adverse reactions occurred in 9% of patients (Grade 3-4, 2.7%).

The recommended dosing of nivolumab is 240 mg (for adults and paediatric patients weighing ≥40 kg) or 3 mg/kg (for paediatric patients weighing <40 kg), administered intravenously in combination with AVD on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Primary G-CSF prophylaxis is recommended starting in Cycle 1.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Israeli Ministry of Health (IMoH), Australian Therapeutic Goods Administration (TGA), Health Canada (HC), and Switzerland’s Swissmedic (SMC). The applications may still be under review at the other regulatory agencies.

This review was conducted as a Summary Review and used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Expedited Programs

This application was granted priority review and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Source: FDA