Seattle Genetics, Inc. announced that the U.S. Food and Drug Administration has accepted for filing two Biologics License Applications (BLAs) for brentuximab vedotin, including one for the treatment of patients with relapsed or refractory Hodgkin lymphoma and one for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). The FDA administratively separated the original BLA submission and will act individually on the application for each indication. In addition, the FDA has granted a six-month priority review of both applications, and has established an action date of August 30, 2011 under the Prescription Drug User Fee Act (PDUFA). Priority review designation is assigned to drugs that, if approved, would address an unmet medical need for a serious or life-threatening condition. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of Hodgkin lymphoma and ALCL.
Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics said, These filings and priority review designations are an important step forward in our effort to bring brentuximab vedotin to the many relapsed and refractory Hodgkin lymphoma and systemic ALCL patients in need. We look forward to continued interactions with the FDA as they review our brentuximab vedotin BLAs.