US giant Pfizer (NYSE: PFE) has announced that it has received another indication approval from the US FDA for its Adcetris (brentuximab vedotin). The antibody-drug conjugate (ADC) can now be used in combination with lenalidomide and a rituximab product. It is approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL). This includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL). The treatment is for patients who have received two or more lines of systemic therapy and are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy.
Drug Background
Adcetris, an ADC comprised of a CD30-directed monoclonal antibody (mAb), has treated over 55, 000 patients in the US and 140, 000 patients worldwide since its first FDA approval in 2011.
Study Results
The latest approval is based on positive results from the Phase III ECHELON-3 study. The study showed that the Adcetris combination reduced patients’ risk of death by 37% compared to placebo in combination with lenalidomide and rituximab. The overall survival (OS) benefit was consistent across levels of CD30 expression. Furthermore, the safety of the Adcetris combination was consistent with previous findings.-Fineline Info & Tech
