Brentuximab vedotin combination receives EC approval for the treatment of adult patients with untreated Stage III Hodgkin lymphoma

On October 18, 2023, it was announced that brentuximab vedotin, a CD30-directed antibody-drug conjugate, in combination with doxorubicin, vinblastine and dacarbazine (AVD) received approval from the European Commission (EC) for the treatment of adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma. This follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 14, 2023.¹

This approval is based on key findings from the randomized phase III ECHELON-1 trial (NCT01712490) comparing brentuximab vedotin plus AVD to doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). In 1,334 adult patients with previously untreated State III or IV classical Hodkin lymphoma.¹ The study met its primary endpoint of modified progression-free survival as well as the secondary endpoint of overall survival (OS), demonstrating a statistically significant improvement in OS for the brentuximab vedotin plus AVD group.¹ Additionally, the safety profile remained consistent with previous studies.¹