The U.S. Food and Drug Administration (FDA) Approves Nivolumab for Hodgkin Lymphoma

March 20, 2026- On March 20, 2026, the U.S. Food and Drug Administration (FDA) announced it has approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric 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 hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin
• after three or more lines of systemic therapy that includes autologous HSCT.

Nivolumab is a checkpoint inhibitor that binds to the programmed death receptor-1 (PD-1). Checkpoint inhibitors are monoclonal antibodies that recognize immune checkpoint proteins. Checkpoint proteins (such as PD-1/PD-L1) regulate (activate or slow down) the immune responses against the body’s own cells.

“This FDA approval of nivolumab in combination with chemotherapy represents a meaningful step in the treatment journey for adolescents and adults with Hodgkin lymphoma,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “For patients and families, advances like this offer renewed hope for more effective and potentially less toxic options at diagnosis.”

For more information on the FDA approval of nivolumab (Opdivo, Bristol Myers Squibb Company), visit the FDA’s website. To learn more about treatment options for Hodgkin lymphoma, visit the Foundation’s Hodgkin lymphoma learning center.