> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Seattle Genetics sBLA for Adcetris
- URL: https://www.fdaweb.com/seattle-genetics-sbla-for-adcetris/
- Published: 2017-08-16T12:00:00.000Z
- Updated: 2026-09-14T22:41:33.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5139399

FDA has accepted for priority review a Seattle Genetics supplemental BLA for Adcetris (brentuximab vedotin) for use in patients with cutaneous T-cell lymphoma. The submission is based on data from the Phase 3 ALCANZA trial and two phase 2 investigator-sponsored trials. The agency has set a user fee review target date of 12/16\. “Results from our positive phase 3 ALCANZA trial demonstrated that using Adcetris in this setting significantly improved the rate of objective responses lasting at least four months with a manageable safety profile,” the company says.