FDA accepts SGEN's brentuximab vedotin BLAs for Hodgkin lymphoma, ALCL treatment

Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that the U.S. Food and Drug Administration (FDA) 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.

"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," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We look forward to continued interactions with the FDA as they review our brentuximab vedotin BLAs."

Seattle Genetics announced on February 28, 2011 that it had submitted a BLA for brentuximab vedotin based on results from both a pivotal trial in relapsed or refractory Hodgkin lymphoma and a phase II trial in relapsed or refractory systemic ALCL that were presented at the American Society of Hematology (ASH) Annual Meeting in December 2010. The pivotal trial in Hodgkin lymphoma was conducted under a Special Protocol Assessment (SPA) with the FDA. Brentuximab vedotin has been granted orphan drug designation by the FDA for the treatment of Hodgkin lymphoma and ALCL.