Takeda has announced that Adcetris (brentuximab vedotin) has been approved by the European Commission (EC) as part of a combination treatment for adults with previously untreated CD30+ stage 3 Hodgkin lymphoma.
The antibody-drug conjugate (ADC), which is already approved in the EU for certain lymphoma patients, can now be used alongside doxorubicin, vinblastine and dacarbazine (AVD) for this subset.
The regulator’s latest decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and is supported by results from the late-stage ECHELON-1 trial, which was designed to compare Adcetris plus AVD to doxorubicin, bleomycin, vinblastine, and dacarbazine in more than 1,300 adults with previously untreated stage 3 or 4 Hodgkin lymphoma.
The study met its key primary and secondary endpoints, demonstrating a statistically significant improvement in modified progression-free survival and overall survival in patients treated with the Adcetris combination.
The safety profile of Adcetris was consistent with previous studies and no new safety signals were observed, Takeda said.
Awny Farajallah, head of global medical affairs oncology at Takeda, said the company was “thrilled” with the approval.
“These patients now have Adcetris as a treatment option, and the significant improvement in survival outcomes that Adcetris may provide when added to a frontline treatment regimen, as evidenced by the ECHELON-1 clinical trial data,” he said.
Hodgkin lymphoma occurs when white blood cells called lymphocytes grow out of control, causing swollen lymph nodes and growths throughout the body.
The disease is distinguished from other types of lymphoma by the presence of one characteristic type of cell known as the Reed-Sternberg cell. These cells typically have a special protein on their surface called CD30, which is a key marker of Hodgkin lymphoma.
Being jointly developed by Takeda and Seagen, Adcetris is made up of a monoclonal antibody that binds to CD30, linked to monomethyl auristatin E, a cytotoxic molecule.
The monoclonal antibody delivers monomethyl auristatin E to the CD30-positive cancer cells.
The cytotoxic molecule then enters the cancer cells and stops them from dividing, and the cancer cells eventually die.
Under the terms of the collaboration agreement, Seagen has US and Canadian commercialisation rights, while Takeda has rights to commercialise Adcetris in the rest of the world.