Seattle Genetics, Inc. Submits Supplemental BLA to FDA for Retreatment and Extended Duration of Therapy With ADCETRIS® (Brentuximab Vedotin) in Relapsed Hodgkin Lymphoma and Systemic ALCL
Published: Mar 18, 2013
BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) supporting the use of ADCETRIS (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL.