Takeda Secures European Commission Approval for ADCETRIS® in Combination with ECADD as a New Frontline Therapy for Adults with Advanced-Stage Hodgkin Lymphoma
Takeda has announced a major milestone in the treatment landscape for Hodgkin lymphoma with the European Commission’s (EC) approval of ADCETRIS® (brentuximab vedotin) in combination with a multi-agent chemotherapy regimen known as ECADD. This combination, which includes etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone, will now be available as a frontline treatment for adult patients newly diagnosed with Stage IIb Hodgkin lymphoma with risk factors, Stage III, or Stage IV disease.
The EC’s decision to authorize the use of ADCETRIS in this setting was informed by a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025. It also follows the growing momentum within the oncology community to optimize frontline therapies that not only enhance efficacy but also reduce the toxicities associated with aggressive chemotherapy.
A New Option for a Challenging Disease
Hodgkin lymphoma is a rare but highly curable cancer that originates in the lymphatic system. It is characterized by the presence of Reed-Sternberg cells and is most commonly diagnosed in young adults and individuals over the age of 55. Although the disease is considered one of the more treatable cancers, patients with advanced-stage disease (Stage IIb with risk factors, Stage III or IV) often face significant challenges, including treatment-related toxicities and a risk of relapse.
Until now, one of the most commonly used frontline regimens for advanced Hodgkin lymphoma in Europe has been eBEACOPP, a highly intensive combination chemotherapy regimen. While eBEACOPP has shown strong efficacy, its aggressive toxicity profile often leads to long-term complications, including infertility, secondary cancers, and damage to the lungs and other organs. The need for a more tolerable yet equally effective alternative has been a high priority in hematologic oncology.
The Promise of ADCETRIS and the BrECADD Regimen
ADCETRIS, also known by its generic name brentuximab vedotin, is an antibody-drug conjugate (ADC) that targets CD30, a transmembrane receptor protein highly expressed in classical Hodgkin lymphoma. The ADCETRIS molecule consists of an anti-CD30 monoclonal antibody attached to a microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable linker. Once the ADC binds to CD30-expressing cells, it is internalized and releases the cytotoxic agent, inducing apoptosis in malignant cells.
Previously, ADCETRIS has received EU approval across six indications, including relapsed or refractory Hodgkin lymphoma and CD30-positive T-cell lymphomas. With this new approval, the drug now becomes part of the BrECADD regimen—a frontline combination that omits some of the more toxic components of eBEACOPP, such as bleomycin and procarbazine, and instead incorporates ADCETRIS for its targeted activity.
HD21 Trial: Foundation of the Approval
The approval is supported by compelling data from the randomized Phase 3 HD21 trial, which was conducted under the auspices of the German Hodgkin Study Group (GHSG), a globally respected leader in Hodgkin lymphoma research. The trial enrolled adult patients with newly diagnosed advanced-stage Hodgkin lymphoma and compared the efficacy and safety of the BrECADD regimen versus the traditional eBEACOPP regimen.
The HD21 trial met both of its co-primary endpoints—non-inferior progression-free survival (PFS) and improved treatment-related morbidity (TRMB). Specifically, the BrECADD arm demonstrated significantly lower rates of severe adverse events while maintaining robust anti-tumor efficacy. Non-inferiority in PFS means that BrECADD performed at least as well as eBEACOPP in preventing disease progression or death, a critical benchmark in cancer treatment trials.
Expert Commentary: A Paradigm Shift in First-Line Treatment
Dr. Peter Borchmann, MD, PhD, of the University Hospital of Cologne in Germany and the trial chairman of the HD21 study, emphasized the transformative potential of the new regimen.
“With BrECADD, patients now have a treatment option that not only offers greater curative potential but also significantly reduces treatment-related morbidity compared to eBEACOPP,” said Dr. Borchmann. “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.”
His remarks underscore the importance of evolving treatment paradigms in oncology—not merely striving for better survival statistics but also ensuring that patients can maintain a higher quality of life during and after treatment.
Takeda’s Vision for Oncology
The approval further strengthens Takeda’s position as a leader in the oncology space, particularly within hematologic malignancies. Teresa Bitetti, President of Takeda’s Global Oncology Business Unit, reflected on the company’s commitment to providing innovative, patient-centered treatments.
“Today’s approval represents a significant advancement for patients with Hodgkin lymphoma in the European Union,” Bitetti stated. “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.”
The introduction of ADCETRIS in combination with ECADD into frontline care offers a notable evolution from older, more toxic regimens, allowing clinicians to better balance efficacy and tolerability.
Addressing Unmet Needs and Future Implications
The EC’s approval of ADCETRIS in combination with ECADD is not only a win for Takeda but also a significant development for the broader medical community. Many patients with Hodgkin lymphoma face long treatment journeys that affect fertility, mental health, and long-term organ function. The ability to offer a more targeted and tolerable regimen at the outset of treatment could help reduce the incidence of late-stage complications and improve survivorship outcomes.
Additionally, this approval may pave the way for further research into ADC-based combinations in other lymphoma subtypes and even solid tumors. As biopharmaceutical innovation continues to shift toward targeted therapies and immuno-oncology, ADCETRIS remains a cornerstone of Takeda’s oncology pipeline and may serve as a model for other antibody-drug conjugates in development.
The European Commission’s approval of ADCETRIS in combination with ECADD as a first-line treatment for adults with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma marks a meaningful advancement in hematologic oncology. Backed by the robust findings of the Phase 3 HD21 trial, this new regimen offers a critical alternative to traditional high-intensity chemotherapies like eBEACOPP.
As clinicians across Europe begin to adopt BrECADD into their treatment protocols, patients stand to benefit from improved safety, sustained efficacy, and greater hope for long-term remission. This latest milestone affirms Takeda’s commitment to transforming cancer care by offering therapies that improve both survival outcomes and quality of life.
