FDA
FDA OK’s Opdivo combo for previously untreated classical Hodgkin lymphoma
On March 20, 2026, FDA approved Opdivo (nivolumab) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients ≥12 years of age with previously untreated, stage III or IV classical Hodgkin lymphoma (cHL). The agency also granted traditional approval to nivolumab for the following indications in adults with relapsed or refractory cHL:
- after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin
- after three or more lines of systemic therapy that includes autologous HSCT.
Efficacy and safety
Efficacy of nivolumab in combination with AVD was evaluated in Study CA209-8UT (SWOG 1826; NCT03907488), a randomized, open-label, multicenter trial in patients ≥12 years of age with previously untreated, stage III and IV cHL. A total of 994 patients were randomized (1:1) to receive either nivolumab plus AVD or brentuximab vedotin plus AVD for 6 cycles.
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% confidence interval, 0.27-0.67; p-value <0.0001). 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, mortality rate was 1.8% 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%).
Recommended dose
Recommended dosing of nivolumab is 240 mg (for adults and pediatric patients weighing ≥40 kg) or 3 mg/kg (for pediatric patients weighing <40 kg), administered IV 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.
Source:
FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma. [News release]. 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-chemotherapy-previously-untreated-hodgkin-lymphoma
Opdivo (nivolumab) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125554s135lbl.pdf Revised March 2026. Accessed March 25, 2026.
