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# FDA Accepts Seattle Genetics sBLA for Adcetris
- URL: https://www.fdaweb.com/fda-accepts-seattle-genetics-sbla-for-adcetris/
- Published: 2018-01-02T12:00:00.000Z
- Updated: 2026-09-14T23:09:31.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5140387

FDA has accepted for review a Seattle Genetics supplemental BLA for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The agency granted a priority review, and set a user fee review target date of 5/1\. The submission is based on data from a Phase 3 clinical trial called ECHELON-1 that was designed to determine if Adcetris in combination with chemotherapy could extend modified progression-free survival (modified PFS) in previously untreated advanced classical Hodgkin lymphoma patients.

FDA originally approved Adcetris in 2011 for treating Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma. The therapy is described by the company as an antibody-drug conjugate directed to CD30, a defining marker of classical Hodgkin lymphoma. It is being evaluated globally for treating CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.