European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30+ stage III Hodgkin Lymphoma in combination with AVD chemotherapy. - Takeda

Adcetris is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in Europe in six distinct indications, including those with previously untreated CD30+ Stage IV Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 14, 2023.

The approval is based on the results of the randomized Phase III ECHELON-1 trial designed to compare Adcetris plus AVD to doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) as a therapy in adult patients with previously untreated Stage III or IV Hodgkin lymphoma. The trial met its primary endpoint of modified progression-free survival (PFS), as well as its key secondary endpoint of overall survival (OS), demonstrating a statistically significant improvement in OS in adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma treated with ADCETRIS+AVD. The safety profile of Adcetris was consistent with previous studies, and no new safety signals were observed.

“ECHELON-1 is the first trial to show a statistically significant improvement in overall survival outcomes for adult patients with Stage III & IV Hodgkin lymphoma in two decades, demonstrating the benefit ADCETRIS continues to bring to a broad group of patients,” said John Radford, M.D., FMedSci, University of Manchester and the Christie NHS Foundation, lead investigator of the ECHELON-1 trial. “This approval is an exciting advancement in care, allowing even more lymphoma patients to access the proven efficacy, consistent safety, and tolerability that ADCETRIS is known to deliver."