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FDA grants breakthrough therapy designation to Adcetris for common CTCL subtypes
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The FDA granted breakthrough therapy designation to brentuximab vedotin for the treatment of patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma, the most common subtypes of cutaneous T-cell lymphoma.
This designation applies to use of the agent by patients who require systemic therapy and have received one prior systemic therapy.
The randomized phase 3 ALCANZA trial compared brentuximab vedotin — an antibody–drug conjugate directed to CD30 — with investigator’s choice of standard therapies in 131 patients with CD30-expressing cutaneous T-cell lymphoma (CTCL) who received prior systemic or radiation therapy.
The trial met its primary endpoint, showing brentuximab vedotin was associated with a statistically significant improvement in the rate of objective response lasting for at least 4 months.
Seattle Genetics intends to submit a supplemental biologics license application to the FDA in the first half of next year to seek approval of brentuximab vedotin in this setting.
“The decision by the FDA to grant brentuximab vedotin breakthrough therapy designation further reinforces our belief that brentuximab vedotin represents a meaningful advance in the treatment of CD30-expressing CTCL,” Clay Siegall, PhD, president and CEO of Seattle Genetics, said in a company-issued press release. “The breakthrough therapy designation supports our goal to expedite the review and approval process to make brentuximab vedotin available to patients in this setting who may benefit.”