FDA Approves Pfizer's ADCETRIS Combination for Relapsed/Refractory Large B-Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has approved Pfizer Inc.'s ADCETRIS® (brentuximab vedotin) 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), who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy.

The approval is based on efficacy and safety data from the Phase 3 ECHELON-3 study. The trial demonstrated that the ADCETRIS combination reduced the risk of death by 37% compared to a placebo in combination with lenalidomide and rituximab, showing a statistically significant and clinically meaningful improvement in overall survival (OS).

LBCL is a type of non-Hodgkin lymphoma, with DLBCL being the most common and aggressive form. More than 25,000 cases of DLBCL are diagnosed annually in the United States, and up to 40% of patients relapse or have refractory disease after initial treatment.

ECHELON-3 is the first Phase 3 trial to demonstrate an OS advantage over lenalidomide and rituximab plus placebo for patients who have received two or more prior lines of therapy. The study also showed positive outcomes in overall response rate (ORR) and progression-free survival (PFS).

The safety profile of ADCETRIS in the ECHELON-3 study was consistent with its known profile. The most frequent Grade 3 or higher treatment-emergent adverse events were neutropenia, thrombocytopenia, and anemia. Study data was published in JCO Oncology Practice in January 2025 and presented at the 2024 ASCO Annual Meeting.