Takeda’s ADCETRIS Regimen Moves Closer to EU Approval
In a significant development for the treatment of advanced Hodgkin lymphoma, Takeda has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the European Commission (EC) approve ADCETRIS® (brentuximab vedotin) in combination with the BrECADD chemotherapy regimen.
This recommendation applies to adults newly diagnosed with stage IIb Hodgkin lymphoma with risk factors, as well as stage III and IV disease.
The marketing authorisation application will now proceed to review by the European Commission, with a final decision anticipated in the coming months. If granted, the authorisation would be valid in all 27 EU member states, in addition to Norway, Liechtenstein, and Iceland – broadening access to what could become a new frontline therapy for thousands of patients across Europe.
This regulatory momentum is underpinned by robust findings from the phase 3 HD21 trial, sponsored by the German Hodgkin Study Group and supported by Takeda.
The study evaluated the efficacy and safety of ADCETRIS in combination with BrECADD compared to the current European standard of care, escalated BEACOPP (eBEACOPP). Crucially, the results demonstrated a significant improvement in safety, particularly in reducing treatment-related morbidity, while showing non-inferior progression-free survival (PFS).
The HD21 trial focused on patients with advanced Hodgkin lymphoma, including those presenting with stage IIb disease marked by large mediastinal masses or extranodal lesions.
Participants initially received two cycles of either eBEACOPP or BrECADD, after which positron emission tomography (PET) scans guided subsequent treatment. The co-primary endpoints of the study – treatment-related morbidity and PFS – were supplemented by secondary measures including overall survival, complete response rate, and quality of life indicators.
Hodgkin lymphoma is a malignancy of the lymphatic system, uniquely characterised by the presence of Reed-Sternberg cells expressing the CD30 protein. ADCETRIS is an antibody-drug conjugate specifically engineered to target CD30, delivering cytotoxic agents directly to malignant cells while aiming to spare healthy tissue.
In 2022, more than 82,000 people were diagnosed with Hodgkin lymphoma worldwide, with around 23,000 deaths, as reported by the International Agency for Research on Cancer.
Should EC approval follow, the ADCETRIS plus BrECADD regimen would represent a meaningful step forward in the standard of care for advanced Hodgkin lymphoma. It would provide an innovative, targeted approach with a favourable safety profile – bringing new hope to patients and clinicians navigating the complexities of this aggressive cancer.
In summary
Takeda’s ADCETRIS, backed by strong clinical evidence and a CHMP nod, is now on the cusp of European approval.
If authorised, this treatment combination could redefine how advanced Hodgkin lymphoma is managed across Europe, offering a more tolerable and equally effective option for those affected by this life-threatening disease.
News Credits: Takeda’s Adcetris receives positive opinion for Hodgkin lymphoma treatment
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