What is the FDA‑approved label for nivolumab in classical Hodgkin lymphoma (≥12 years) after autologous stem‑cell transplantation and brentuximab vedotin failure?

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Last updated: February 6, 2026 • View editorial policy

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FDA-Approved Label for Nivolumab in Classical Hodgkin Lymphoma

Nivolumab is FDA-approved for adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, OR after 3 or more lines of systemic therapy that includes autologous HSCT. 1

Specific FDA Indications

The FDA label specifies two distinct pathways for nivolumab use in cHL 2, 1:

  • Pathway 1: Patients with cHL that has relapsed or progressed after both autologous HSCT and post-transplantation brentuximab vedotin 1, 3
  • Pathway 2: Patients who have received 3 or more lines of systemic therapy that includes autologous HSCT 1

Important Regulatory Context

This indication was granted under accelerated approval based on overall response rate, and continued approval is contingent upon verification of clinical benefit in confirmatory trials. 1, 3

Age Restrictions and Pediatric Considerations

Nivolumab has NOT been studied in pediatric patients with Hodgkin lymphoma; therefore, the FDA approval is limited to adult patients only. 2 The NCCN explicitly states that for pediatric patients requiring checkpoint inhibitor therapy, only pembrolizumab should be offered, as it has been studied and approved for both adult and pediatric patients with refractory cHL. 2

Clinical Context from Pivotal Trials

The accelerated approval was based on two single-arm multicenter trials 3:

  • Objective response rate: 65-69% across cohorts (95% CI: 55-75%) 3, 4, 5
  • Complete remission rate: 7-8% 3, 4
  • Partial remission rate: 58-66% 3, 4
  • Median duration of response: 8.7-16.6 months with extended follow-up 3, 5
  • Median time to response: 2.1 months (range: 0.7-5.7 months) 3

Dosing Specifications

The standard nivolumab dose for cHL is 3 mg/kg intravenously every 2 weeks until disease progression, unacceptable toxicity, or treatment discontinuation. 3, 4, 5

Critical Safety Warning

A new FDA Warning and Precaution was issued specifically for complications of allogeneic HSCT after nivolumab, including severe or hyperacute graft-versus-host disease, other immune-mediated adverse reactions, and transplant-related mortality. 3 The NCCN advises caution when using checkpoint inhibitors post-allogeneic transplant due to increased risk of GVHD and immunological complications. 2

Common Adverse Reactions

The most common adverse reactions (≥20% of patients) include 3:

  • Fatigue (25%)
  • Upper respiratory tract infection
  • Cough
  • Pyrexia
  • Diarrhea
  • Elevated transaminases
  • Cytopenias

Serious adverse reactions occurred in 21% of patients, with grade 3-4 treatment-related adverse events in 12-20%. 2, 3

NCCN Guideline Recommendations for Use

The NCCN commonly recommends checkpoint inhibitors for 2:

  • Patients with refractory cHL who are transplant-ineligible based on comorbidity or failure of first salvage chemotherapy
  • Any patient who has relapsed after autologous HSCT ± brentuximab vedotin
  • Post-allogeneic transplant patients (with caution due to GVHD risk)

References

2
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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