12 February 2025 - On 11 February 2025, the FDA approved brentuximab vedotin (Adcetris, Seagen) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma arising from indolent lymphoma, or high-grade B-cell lymphoma, after two or more lines of systemic therapy who are ineligible for autologous haematopoietic stem cell transplantation or CAR T-cell therapy.
Approval was based on ECHELON-3, a randomised, double-blind, placebo-controlled trial enrolling 230 adult patients with relapsed or refractory large B-cell lymphoma who were ineligible to receive an autologous haematopoietic stem cell transplantation or CAR T-cell therapy.