The U.S. Food and Drug Administration (FDA) has approved a new treatment regimen that includes Pfizer’s ADCETRIS® (brentuximab vedotin) for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This is an important development as it provides a new option for individuals who have not responded to at least two previous therapies and are not candidates for more aggressive treatments such as stem cell transplantation or CAR T-cell therapy.
This approval stems from the Phase 3 ECHELON-3 trial, which demonstrated that the ADCETRIS regimen lowered the risk of death by 37% when compared to a combination of lenalidomide and rituximab plus placebo. Notably, this is the first Phase 3 trial to show an overall survival benefit in this particular group of patients. The study included participants who had undergone extensive prior treatments, including some who had received CAR-T therapy.
DLBCL is a fast-growing type of non-Hodgkin lymphoma that targets B lymphocytes, which are essentially white blood cells in the immune system. Despite advancements in treatment, there is still a significant need for options for patients who cannot access current therapies or whose disease recurs after treatment. The ECHELON-3 study revealed consistent benefits across various levels of CD30 expression, a marker that helps predict the success of certain treatments.
The safety profile of ADCETRIS observed in the ECHELON-3 trial aligned with what is already known about its safety. The most frequently reported serious side effects included neutropenia (a decrease in white blood cells), thrombocytopenia (a drop in platelet count), and anemia (a reduction in red blood cells). Peripheral sensory neuropathy, which affects the nerves, is rare and typically mild.
ADCETRIS is an antibody-drug conjugate that specifically targets CD30-positive tumor cells. Since its initial approval in 2011, it has been used to treat over 140,000 patients worldwide. This latest approval represents its eighth indication in the U.S., reinforcing its position as a standard treatment option for certain types of lymphomas.
Source: https://finance.yahoo.com/news/u-fda-approves-pfizer-adcetris-171500285.html
