Takeda has announced that the European Commission (EC) has extended the current marketing authorisation of Adcetris (brentuximab vedotin) to include treatment of adults with previously untreated CD30+ Stage IV Hodgkin lymphoma.
The approval is for the drug in combination with AVD (Adriamycin, vinblastine and dacarbazine) and follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 13, 2018.
The decision by the EC is based on results of the Phase III ECHELON-1 study, which demonstrated that the addition of the drug and the removal of bleomycin from the standard ABVD regimen yielded both efficacy and safety benefits in patients.
“The decision by the European Commission is a welcomed advancement for patients with previously untreated Stage IV Hodgkin lymphoma – a population that has not been offered a new treatment option in decades,” said Anna Sureda, head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Català d’Oncologia.
“Patients with Stage IV disease carry a higher risk of progression following their first therapy and experience poorer outcomes as a result.
"The approval of this regimen may help address this unmet need by providing European physicians and their patients with a new option that showed significant benefit compared to ABVD along with a safety profile consistent with when Adcetris is used as a single agent.”
The approval marks the first new treatment in decades for those in need, with up to 30% of previously untreated Hodgkin lymphoma patients progressing following their first therapy, and patients in Stage IV carrying an even higher risk than those with early-stage disease.