Marketing authorisation of Adcetris has been expanded in Europe to include the treatment of patients with previously untreated CD30+ Stage IV Hodgkin lymphoma.
Adcetris is an antibody-drug conjugate jointly developed by Takeda and Seattle Genetics directed at CD30, a defining marker of Hodgkin lymphoma.
The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 13, 2018.
The approval is based on the results of the Phase 3 ECHELON-1 study designed to compare Adcetris plus AVD to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) as a therapy in adult patients with previously untreated Hodgkin lymphoma.
Jesús Gómez-Navarro, Vice President, Head of Oncology Clinical Research and Development, Takeda, said: “The ECHELON-1 clinical trial demonstrated that the addition of Adcetris and the removal of bleomycin from the standard ABVD regimen yielded both efficacy and safety benefits in patients.”
The decision from the European Commission means that Adcetris in combination with AVD is now approved for marketing of this indication in the 28 member states of the European Union and applicable in Norway, Liechtenstein and Iceland.