Seattle Genetics Inc. has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration using data from its recent Phase 3 Alcanza trial and two Phase 2 investigator-sponsored trials of Adcetris.
Adcetris treats patients with cutaneous T-cell lymphoma.
“The submission of the supplemental BLA requesting label expansion for Adcetris as a treatment in CTCL patients who require systemic therapy is an important milestone. CTCL is an incurable and disfiguring disease in need of new therapeutic options, particularly those that achieve durable responses,” Dr. Jonathan Drachman, chief medical officer of Seattle Genetics, said in a statement.
Drachman noted that the trial results showed CTCL patients to have superior outcomes for all endpoints when treated with Adcetris over patients who received either methotrexate or bexarotene standard of care agents.
“In addition to the Alcanza results, data from two investigator-sponsored trials also support Adcetris use in this disease setting,” Drachman said. “We believe these data are clinically meaningful and support a label expansion for Adcetris in CTCL, which would be the fourth indication for this program.”
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