The U.S. Food and Drug Administration (FDA) Approves Brentuximab Vedotin with Lenalidomide and Rituximab for Relapsed or Refractory Large B-cell Lymphoma

February 12, 2025 – On February 12, 2025, the U.S. Food and Drug Administration (FDA) announced it has approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.

Brentuximab vedotin (Adcetris) is a type of immunotherapy called antibody-drug conjugates (ADC). ADC’s are monoclonal antibodies attached to a chemotherapy drug. These agents target lymphoma cells by attaching to a protein on the cell surface, such as CD30. The ADC enters the cell, where the chemotherapy drug separates from the antibody portion and kills the cell by targeting a critical cell function, such as cell division.

“The FDA’s approval of this combination therapy marks a significant advancement for patients battling relapsed or refractory large B-cell lymphoma,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “Expanded treatment options bring renewed hope to patients and their families, reinforcing the urgent need for continued innovation in blood cancer research.”

For more information on the FDA approval of brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer), visit the FDA’s website.