Takeda has announced that the European Medicines Agency’s human medicines committee has recommended Adcetris (brentuximab vedotin) as part of a combination treatment in adults with previously untreated CD30+ stage 3 Hodgkin lymphoma.
The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that the antibody-drug conjugate (ADC), which is already approved in the EU for certain lymphoma patients, be used alongside doxorubicin, vinblastine and dacarbazine (AVD) for this subset.
The positive opinion was supported by results from the phase 3 ECHELON-1 trial, which was designed to compare Adcetris plus AVD to doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) 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.
The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 27 EU member states, as well as Norway, Liechtenstein and Iceland.
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, present in lymph nodes. These cells typically have a special protein on their surface called CD30, which is a key marker of Hodgkin lymphoma.
Jointly being 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.