Takeda has received approval from the European Commission (EC) for its Pfizer-partnered blood cancer drug Adcetris (brentuximab vedotin).
The drug has been approved in combination with the chemotherapy regimen etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) to treat newly diagnosed stage 2b Hodgkin lymphoma (HL) in adults with risk factors/3/4.
The authorisation follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the phase 3 HD21 study.
The trial achieved its co-primary endpoints, with the Adcetris regimen demonstrating significantly improved safety, as assessed by treatment-related morbidity, and non-inferior progression-free survival compared to escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone (eBEACOPP), a standard of care in Europe.
HD21 trial chairman, Peter Borchmann, University Hospital of Cologne, said: “With [the Adcetris regimen], 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 front-line treatment of adults with advanced stage HL, contributing to improved long-term outcomes for patients.”
HL originates from abnormal lymphocytes and is distinguished from other types of lymphoma by the presence of Reed-Sternberg cells, which typically carry the CD30 protein on their surface. Approximately 82,469 new cases of the disease were reported globally in 2022.
Adcetris, an antibody-drug conjugate (ADC) directed at CD30, is already approved in the EU for six other adult indications and the EC’s latest decision marks the second approval for an Adcetris-based combination regimen for front-line HL.
Teresa Bitetti, president of Takeda’s global oncology business unit, said the approval “represents a significant advancement for patients with HL in the EU”.
“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,” Bitetti added.
Takeda is responsible for Adcetris’ commercialisation everywhere except the US and Canada, where Pfizer holds commercialisation rights.