“This is one of several brentuximab vedotin regulatory milestones during 2017 towards our goal of expanding its availabilty globally to patients in need. We recently submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for brentuximab vedotin approval in cutaneous T-cell lymphoma based primarily on our phase III ALCANZA clinical trial, and we plan to submit a supplemental BLA to the FDA for brentuximab vedotin in frontline Hodgkin lymphoma based on the positive phase III ECHELON-1 clinical trial. We plan to follow up with submissions to Health Canada for indications in these settings,” Siegall added.
Brentuximab vedotin is currently not approved for use in Cutaneous T-Cell Lymphoma (CTCL) or frontline Hodgkin lymphoma.
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