Japanese pharmaceutical company Takeda has secured European Commission (EC) approval for Adcetris (brentuximab vedotin) in combination with chemotherapy to treat Hodgkin lymphoma in adults.
The chemotherapy includes etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone (ECADD).
Adcetris is an antibody-drug conjugate (ADC) that targets CD30-positive tumour cells.
The ADC is linked to a microtubule-disrupting agent, monomethyl auristatin E (MMAE), using Pfizer’s proprietary technology.
Its linker system is designed to remain stable in the bloodstream and release MMAE upon internalisation into tumour cells.
Adcetris was previously approved in the European Union (EU) for six indications.
The current EC approval is its second approval for a combination regimen in frontline Hodgkin lymphoma, widening treatment options for patients with historically limited choices.
It follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in April this year.
Takeda global oncology business unit president Teresa Bitetti said: “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.”
The EC approval is supported by results from the Phase 3 HD21 trial, conducted by the German Hodgkin Study Group (GHSG).
It is an open label, randomised, multicentre trial that assessed the BrECADD regimen’s feasibility, efficacy, safety, and tolerability in patients with advanced Hodgkin lymphoma.
The HD21 trial aimed to evaluate a new treatment regimen that minimises side effects while maintaining effective responses.
Co-primary endpoints included safety, assessed by treatment-related morbidity (TRMB), and efficacy, measured by progression-free survival (PFS).
Secondary endpoints were tumour response, overall survival, infertility rate, second malignancies, adverse events, therapy adherence, and quality of life.
The clinical trial met its co-primary safety and efficacy endpoints, with BrECADD showing significantly superior safety and non-inferior PFS compared to escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (eBEACOPP), a standard treatment in Europe.
Adcetris is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients, and bleomycin, and it causes pulmonary toxicity.
HD21 study trial chairman Peter Borchmann said: “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.
“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.”
