Brentuximab vedotin in combination with lenalidomide and rituximab receives U.S. FDA approval for the treatment of R/R LBCL

On February 11, 2025, it was announced that the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (BV) in combination with lenalidomide (Len) and rituximab (R), for the treatment of adult patients with relapsed or refractory (R/R) 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 ≥2 lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptors (CAR) T-cell therapy.¹ This approval was based on positive results from the phase III ECHELON-3 (NCT04404283) trial.¹

ECHELON-3 trial

ECHELON-3 is a randomized, double-blind, placebo (Pbo)-controlled, phase III trial evaluating the efficacy and safety of BV+Len+R vs Pbo+Len+R in patients with R/R LBCL who received ≥2 prior lines of systemic therapy and were ineligible to receive an auto-HSCT or CAR T-cell therapy. Among the intention-to-treat population (n = 230):^1,2  

The recommended BV dose is 1.2 mg/kg up to a maximum of 120 mg in combination with Len and R to be administered every three weeks until disease progression or unacceptable toxicity.