The Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (BLA) for Seattle Genetics’ (SGEN) product Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The Agency granted Priority Review for the application, and the Prescription Drug User Fee Act (PDUFA) target action date is May 1, 2018.
The BLA is based on positive results from a phase 3 ECHELON-1 trial designed to determine if Adcetris in combination with chemotherapy could extend modified . . .