Posted by Michael Wonder on 02 Jan 2018
FDA accepts supplemental biologics license application and grants priority review for Adcetris (brentuximab vedotin) in front-line advanced Hodgkin's lymphoma
2 January 2018 - Submission based on positive results from the Phase 3 ECHELON-1 clinical trial.
Seattle Genetics announced today that the U.S. FDA has accepted for filing a supplemental biologics license application for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma.
The FDA granted priority review for the application, and the Prescription Drug User Fee Act target action date is 1 May 2018.
