Cambridge, Mass.– The European Commission has approved Takeda’s ADCETRIS® (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone (ECADD) for the treatment of adult patients with newly diagnosed Stage IIb with risk factors, Stage III, or Stage IV Hodgkin lymphoma. The decision follows a favorable opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in April and marks the second frontline approval for an ADCETRIS-based regimen in the European Union.
The approval is based on data from the Phase 3 HD21 trial, which compared the ADCETRIS-based regimen—known as BrECADD—with the current European standard, eBEACOPP. BrECADD met both co-primary endpoints, demonstrating a superior safety profile and non-inferior progression-free survival. The study was conducted by the German Hodgkin Study Group and aimed to reduce treatment-related morbidity while maintaining therapeutic efficacy in patients with advanced Hodgkin lymphoma.
Takeda’s oncology leadership emphasized the significance of the milestone, citing ADCETRIS’s growing role in the treatment of CD30-positive lymphomas. Teresa Bitetti, President of Takeda’s Global Oncology Business Unit, called the approval “a significant advancement for patients” and highlighted the benefit of expanding frontline treatment options tailored to individual patient needs.
Peter Borchmann, MD, PhD, of the University Hospital of Cologne and chair of the HD21 study, noted that BrECADD not only offers promising curative potential but also significantly reduces the toxicities associated with eBEACOPP. He suggested the new combination could become a new standard of care for advanced-stage Hodgkin lymphoma in adults.
ADCETRIS is an antibody-drug conjugate that targets CD30, a key marker of Hodgkin lymphoma. It combines a monoclonal antibody with a cytotoxic agent and has been previously approved in the EU for six other indications. This latest approval adds to its frontline therapeutic reach, offering a new regimen aimed at improving outcomes and minimizing treatment-related harm.
The HD21 trial enrolled patients newly diagnosed with advanced Hodgkin lymphoma and used PET-adapted response assessments to tailor treatment duration. In addition to evaluating safety and progression-free survival, the trial also measured complete response rates, overall survival, adverse events, infertility risk, and quality of life.
Takeda continues to build on ADCETRIS’s success, with the therapy already approved for multiple forms of CD30-expressing lymphomas in both Europe and North America. The BrECADD approval underscores ongoing efforts to refine and personalize treatment strategies for patients facing aggressive forms of Hodgkin lymphoma.
