European Commission approves Adcetris with AVD chemotherapy for untreated CD30+ stage IV classical Hodgkin lymphoma .- Takeda + Seattle Genetics

Seattle Genetics, Inc announced that its collaborator, Takeda Pharmaceutical Company Limited , received approval from the European Commission to extend the marketing authorization for Adcetris (brentuximab vedotin) to include Adcetris in combination with AVD (Adriamycin, vinblastine and dacarbazine) in adults patients with previously untreated CD30+ stage IV classical Hodgkin lymphoma (HL).

The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 13, 2018 . As a result, Seattle Genetics will receive a milestone payment from Takeda of $30 million. Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL that plays a role in tumor growth and survival.

The marketing authorization for Adcetris is based on positive results from the ECHELON-1 phase III clinical trial that were presented in the Plenary Scientific Session at the 59th American Society of Hematology (ASH) annual meeting in December 2017 with simultaneous publication in the New England Journal of Medicine .