Seattle Genetics files sBLA at FDA for Adcetris to treat CD30-expressing peripheral T-cell lymphoma (PTCL).
Seattle Genetics, Inc. announced that it has submitted a supplemental Biologics License Application (BLA) to the FDA based on data from the phase III ECHELON-2 trial evaluating Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma (PTCL).
The positive topline results of the phase III ECHELON-2 clinical trial were announced in October 2018 and full data will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting, December 1-4, 2018 in San Diego, Calif. Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL. Adcetris is currently not approved for the frontline treatment of PTCL.