FDA grants priority review to Adcetris for cutaneous T-cell lymphoma
The FDA granted priority review to brentuximab vedotin for the treatment of cutaneous T-cell lymphoma, according to the drug’s manufacturer.
The agency set a target action date of Dec. 16.
The supplemental biologics license application included topline data from the phase 3 ALCANZA trial, designed to compare brentuximab vedotin (Adcetris, Seattle Genetics) — an antibody-drug conjugate directed to CD30 — with standard therapies in 128 patients with cutaneous T-cell lymphoma (CTCL) that required systemic therapy.
Objective response that lasted at least 4 months (ORR4) served as the primary endpoint. Secondary endpoints included complete response rate, PFS and reduction in symptom burden.
A higher percentage of patients treated with brentuximab vedotin achieved ORR4 (56.3% vs. 12.5%; P < .0001).
Differences in all secondary endpoints also were highly statistically significant in favor of brentuximab vedotin.
The agent’s safety profile appeared consistent with existing prescribing information. The most common adverse events included anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue and neutropenia.
Additional data from two investigator-sponsored phase 2 trials designed to compare brentuximab vedotin with standard therapies also have been incorporated into the supplemental biologics license application to support the potential for a broader label in CTCL.
“The FDA’s filing of our supplemental biologics license application with priority review status represents a significant milestone toward our goal of making Adcetris available to CTCL patients who require systemic therapy,” Jonathan Drachman, MD, chief medical officer and executive vice president of research and development at Seattle Genetics, said in a company-issued press release. “We look forward to working with the FDA during the review of our application for Adcetris in CTCL, which, if approved, would be the fourth indication for this product.”
The FDA previously granted breakthrough therapy designation to brentuximab vedotin for the treatment of patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma who require systemic therapy and have received one prior systemic therapy. These represent the most common CTCL subtypes.