Seattle Genetics

FDA accepts sBLA and grants Priority Review to Seattle Genetics’ brentuximab vedotin for frontline advanced cHL

Seattle Genetics confirms that the Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (sBLA) for brentuximab vedotin (Adcetris) plus AVD (Adriamycin, vinblastine, dacarbazine) compared with a recognized standard of care chemotherapy regimen, ABVD (which includes bleomycin), for the frontline treatment of patients with advanced classical Hodgkin lymphoma (cHL). The FDA granted Priority Review for the application, and the Prescription Drug User Fee Act target action date is May 1, 2018. The submission of the sBLA is based on positive results from ECHELON-1, a phase III clinical trial that was designed to determine if brentuximab vedotin in combination with chemotherapy could extend modified progression-free survival (PFS) in previously untreated advanced cHL patients. The trial achieved its primary endpoint with the combination of brentuximab vedotin plus AVD resulting in a statistically significant improvement in modified PFS vs the control arm of ABVD as assessed by an independent review facility (IRF; P = .035). This corresponds to a 23% reduction in the risk of progression, death, or need for additional anticancer therapy. Per IRF assessment, the 2-year modified PFS rate for patients in the brentuximab vedotin plus AVD arm was 82.1% compared with 77.2% in the control arm. All secondary endpoints, including interim analysis of overall survival, trended in favor of the brentuximab vedotin plus AVD arm. The safety profile of brentuximab vedotin plus AVD in the ECHELON-1 trial was generally consistent with that known for the single-agent components of the regimen.

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