Posted by Michael Wonder on 17 Dec 2018
Takeda receives positive CHMP opinion for Adcetris (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30 positive Stage IV Hodgkin lymphoma in combination with AVD
15 December 2018 - If authorized in Europe, Adcetris in combination with AVD (Adriamycin, vinblastine and dacarbazine) will be the first new treatment regimen available for adult patients with previously untreated CD30 positive Stage IV Hodgkin lymphoma in decades.
Takeda today announced that the EMA's CHMP adopted a positive opinion for the extension of the marketing authorisation of Adcetris (brentuximab vedotin) and recommended its approval in combination with AVD in adult patients with previously untreated CD30 positive Stage IV Hodgkin lymphoma. Adcetris is an antibody-drug conjugate directed at CD30, a defining marker of Hodgkin lymphoma. Adcetris is currently not approved as a therapy for previously untreated Hodgkin lymphoma in Europe.
The positive CHMP opinion is based on the results of the Phase 3 ECHELON-1 study designed to compare Adcetris plus AVD to ABVD as a therapy in adult patients with previously untreated Hodgkin lymphoma.
