Nivolumab Wins Multiple FDA Approvals for Classical Hodgkin Lymphoma

Nivolumab (Opdivo; Bristol Myers Squibb Company) plus doxorubicin, vinblastine, and dacarbazine (AVD) received FDA approval for adult and pediatric patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma (cHL).¹

Supported by data from the CA209-8UT (SWOG 1826; NCT03907488)² study, nivolumab received an additional traditional approval for patients with relapsed refractory cHL. Now, the agent is also approved following autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin (Adcetris; Pfizer, Takeda) and after 3 or more lines of systemic therapy that include autologous HSCT.¹

Nivolumab Combination Improves Survival

CA209-8UT is a randomized, open-label, multicenter phase 3 trial that compared the addition of nivolumab—a PD-1 checkpoint inhibitor—to AVD versus brentuximab vedotin plus AVD. The trial included patients aged 12 and older with previously untreated stage III or IV disease. The patients (n = 994) who were randomly assigned to receive either nivolumab plus AVD or brentuximab vedotin plus AVD for 6 cycles.^1,2

The trial's primary end point of progression-free survival (PFS) demonstrated clear superiority with nivolumab plus AVD. Patients receiving the nivolumab regimen had roughly 58% lower risk of disease progression or death compared with those in the brentuximab vedotin arm.¹

After a median follow-up of about 13.7 months, median PFS had not been reached in either arm, a reflection of the overall favorable outcomes across both groups. At an extended follow-up of 36.7 months, only 1.8% of patients in the nivolumab arm had died, compared with 3.4% in the comparator arm.¹

The findings carry significant implications for how pharmacists approach first-line therapy in this population. Incorporating a checkpoint inhibitor at the outset of treatment—rather than reserving immunotherapy for relapsed or refractory disease—represents a meaningful shift in therapeutic strategy.¹

Safety Outcomes and Recommended Dosing for Nivolumab

Serious adverse effects (AEs) were reported in approximately 39% of patients receiving nivolumab plus AVD, which is a rate consistent with the intensity of combined immunotherapy and chemotherapy. Immune-mediated AEs occurred in 9% of patients overall, with grade 3 and 4 reactions seen in 2.7%. These figures underscore the importance of vigilant monitoring and early intervention protocols in clinical practice.¹

Nivolumab is administered as a 240-mg intravenous (IV) infusion for adults and pediatric patients weighing 40 kg or more or at a weight-based dose of 3 mg/kg IV for pediatric patients weighing less than 40 kg.¹

Dosing follows a fixed schedule on days 1 and 15 of each 28-day cycle, given in combination with AVD chemotherapy, for a total of up to 6 cycles. To reduce the risk of febrile neutropenia associated with this regimen, primary prophylaxis with granulocyte colony-stimulating factor is recommended for all patients beginning with cycle 1.¹

REFERENCES

1. FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma. FDA. March 20, 2026. Accessed March 20, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-chemotherapy-previously-untreated-hodgkin-lymphoma?utm_medium=email&utm_source=govdelivery

2. Immunotherapy (nivolumab or brentuximab Vvdotin) plus combination chemotherapy in treating patients with newly diagnosed stage III-IV classic hodgkin lymphoma. Clinicaltrials.gov. Updated December 4, 2025. Accessed March 20, 2025. https://clinicaltrials.gov/study/NCT03907488