ADCETRIS in Combination with AVD (Adriamycin, Vinblastine and Dacarbazine) Demonstrated 29-Percent Reduction in the Risk of Progression, Death or Need for Additional Anticancer Therapy for CD30+ Stage IV Patients
Seattle Genetics has announced that the US Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) 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 (PDUFA) target action date is May 1, 2018.
The company said its antibody-drug conjugate SGN-LIV1A has shown efficacy in patients with triple-negative metastatic breast cancer—a particularly hard-to-treat patient population—in a Phase I trial presented at the San Antonio Breast Cancer Symposium (SABCS).