Takeda Pharmaceutical Company Limited (NYSE:TAK)’s ADCETRIS® (brentuximab vedotin) in combination with ECADD was authorized by the European Commission on June 3, 2025, for newly diagnosed adult patients with Stage IIb with risk factors, III, or IV Hodgkin lymphoma.
A scientist studying a DNA sample under a microscope in a laboratory.
This clearance, which is based on the Phase 3 HD21 study, is ADCETRIS’ second frontline approval for Hodgkin lymphoma in the EU and comes after a favorable CHMP opinion in April 2025.
Dr. Peter Borchmann of the University Hospital of Cologne led the HD21 trial, which showed that BrECADD significantly reduced treatment-related morbidity while maintaining non-inferior progression-free survival compared to the European standard of care, eBEACOPP.
There are now seven EU indications for the antibody-drug combination ADCETRIS, which targets CD30. The study, which employed PET-adapted treatment throughout Europe, showed BrECADD has better safety and curative potential, making it a viable new frontline standard for advanced Hodgkin disease. In the United States, ADCETRIS is authorized for eight indications.
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Disclosure. None.
