Takeda’s ADCETRIS® Approved In Europe For Frontline Advanced Hodgkin Lymphoma

Takeda has announced that the European Commission has granted approval for ADCETRIS® (brentuximab vedotin) combined with a chemotherapy regimen known as ECADD for the frontline treatment of adults with newly diagnosed advanced-stage Hodgkin lymphoma (Stage IIb with risk factors, III, or IV). This decision was based on a favorable CHMP opinion issued in April 2025.

“Today's approval represents a significant advancement for patients with Hodgkin lymphoma in the European Union. This approval reinforces the role of ADCETRIS as a backbone in the treatment of specific lymphomas, offering healthcare professionals greater flexibility to tailor treatment plans according to individual patient needs. We’re proud to contribute another impactful option for those diagnosed with this challenging disease,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. 

The approval follows data from the Phase 3 HD21 trial, where the BrECADD regimen (ADCETRIS + ECADD) demonstrated superior safety and non-inferior efficacy compared to the standard-of-care eBEACOPP regimen. Specifically, BrECADD achieved lower treatment-related morbidity and comparable progression-free survival rates, signaling a safer and effective new frontline therapy option.

“With BrECADD, patients now have a treatment option that not only offers greater curative potential2 but also significantly reduces treatment-related morbidity compared to eBEACOPP. This new ADCETRIS-based combination therapy may offer a new standard of care for frontline treatment of adults with advanced-stage Hodgkin lymphoma, contributing to improved long-term outcomes for patients,” said Peter Borchmann, MD, PhD, University Hospital of Cologne, Germany, and trial chairman of the HD21 study. 

ADCETRIS, an antibody-drug conjugate targeting CD30, a key marker in Hodgkin lymphoma, has already been authorized in the EU for six different indications. This latest approval expands its role in treating frontline Hodgkin lymphoma, offering a more tolerable treatment choice for patients with historically limited options.