Seattle Genetics (Nasdaq:SGEN) announced on 2/11/19 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.
“Receipt of this milestone payment reflects continued progress by our partner Takeda to expand Adcetris approved indications globally,” said Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “We look forward to continuing our work with Takeda to establish Adcetris as the global foundation of care for CD30-expressing lymphomas, including Hodgkin lymphoma.”
The marketing authorization for Adcetris is based on positive results from the ECHELON-1 phase 3 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.
Seattle Genetics and Takeda are jointly developing Adcetris. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize Adcetris in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for Adcetris on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.