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# FDA Grants Seattle Genetics Breakthrough Status for Adcetris
- URL: https://www.fdaweb.com/fda-grants-seattle-genetics-breakthrough-status-for-adcetris/
- Published: 2016-11-11T12:00:00.000Z
- Updated: 2026-09-14T21:47:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137321

FDA has granted Seattle Genetics a breakthrough therapy designation for Adcetris (brentuximab vedotin) for treating patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy. MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma (CTCL), accounting for more than 75% of the disease, according to the company. Adcetris has been evaluated in CD30-expressing CTCL in investigator- and corporate-sponsored clinical trials, including the phase 3 ALCANZA study, which met its primary endpoint demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months, the company says. Adcetris is an antibody-drug conjugate directed to CD30 which is expressed on skin lesions in approximately 50% of patients with CTCL.