Posted by Michael Wonder on 03 Oct 2017
Seattle Genetics receives FDA breakthrough therapy designation for Adcetris (brentuximab vedotin) in front-line advanced Hodgkin lymphoma
2 October 2017 - Designation based on positive Phase 3 ECHELON-1 trial evaluating Adcetris in front-line advanced Hodgkin lymphoma; data will be presented at upcoming American Society of Hematology Annual Meeting in December.
Seattle Genetics today announced that the U.S. FDA has granted breakthrough therapy designation to Adcetris (brentuximab vedotin) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The positive top-line results of the phase 3 ECHELON-1 clinical trial were announced in June 2017 and full data will be presented at the upcoming American Society of Hematology annual meeting, December 9-12, 2017 in Atlanta, Georgia.
Adcetris is an antibody-drug conjugate directed to CD30, a defining marker of classical Hodgkin lymphoma. Adcetris is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials. Adcetris is currently not approved as a frontline therapy for Hodgkin lymphoma.
