U.S. FDA approves Pfizer’s ADCETRIS combination regimen for the treatment of relapsed/refractory diffuse large B-cell lymphoma

CAR-T Digest - August 2020

12 Feb 2025: U.S. FDA approves Pfizer’s ADCETRIS combination regimen for the treatment of relapsed/refractory diffuse large B-cell lymphoma

The FDA approved ADCETRIS (Brentuximab vedotin) for treating adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including various forms of diffuse large B-cell lymphoma (DLBCL), after two or more lines of therapy
This approval was based on the positive results of the Phase 3 ECHELON-3 trial, which showed that the ADCETRIS regimen reduced the risk of death by 37%, offering a significant improvement in overall survival (OS) compared to the standard treatment of lenalidomide and rituximab plus placebo
ECHELON-3 was the first Phase 3 trial to demonstrate an OS advantage over lenalidomide and rituximab plus placebo for patients with relapsed/refractory DLBCL, regardless of CD30 expression
The approval marks the eighth FDA-approved indication for ADCETRIS, reinforcing its role as a standard treatment for certain types of lymphoma and providing a new option for patients who are not eligible for autologous stem cell transplantation or CAR-T therapy
ADCETRIS offers a new treatment alternative with proven safety and efficacy, providing patients who have failed multiple therapies with a potential outpatient option, backed by significant improvements ORR and PFS