FDA Accepts sBLA and Grants Priority Review for Brentuximab Vedotin in Cutaneous T-Cell Lymphoma
On August 16, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for brentuximab vedotin (Adcetris) in patients with cutaneous T-cell lymphoma (CTCL).
The sBLA and its acceptance is based on data from the phase III ALCANZA trial and two phase II investigator-sponsored trials.
“The FDA’s filing of our sBLA with Priority Review status represents a significant milestone towards our goal of making [brentuximab vedotin] available to CTCL patients who require systemic therapy,” said Jonathan Drachman, MD, Chief Medical Officer and Executive Vice President, Research and Development, Seattle Genetics. “Results from our positive phase III ALCANZA trial demonstrated that using [brentuximab vedotin] in this setting significantly improved the rate of objective responses lasting at least 4 months with a manageable safety profile. Data from two investigator-sponsored trials in a broader patient population were included in the submission to further support [brentuximab vedotin] use in this disease setting.”
ALCANZA Trial
The sBLA is primarily based on positive results ALCANZA that were presented by Kim et al at the 2016 American Society of Hematology (ASH) Annual Meeting (Abstract 182) and published by Prince et al in The Lancet. Results from the ALCANZA trial in 128 CTCL patients requiring systemic therapy included:
- The trial achieved its primary endpoint with the brentuximab vedotin treatment arm demonstrating a highly statistically significant improvement in the rate of objective response lasting at least 4 months (ORR4) vs the control arm as assessed by an independent review facility. ORR4, as assessed by Global Response Score, was 56.3% in the brentuximab vedotin arm compared to 12.5% in the control arm (P < .0001).
- Key secondary endpoints specified in the protocol, including complete response rate, progression-free survival, and reduction in the burden of symptoms during treatment (Skindex-29), were all highly statistically significant in favor of the brentuximab vedotin arm.
- The safety profile associated with brentuximab vedotin from the ALCANZA trial was generally consistent with the existing prescribing information. The most common adverse events of any grade include: anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia.
Based on discussions with the FDA, additional data from two investigator-sponsored phase 2 trials have also been incorporated into the sBLA to support the potential for a broader label in CTCL.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
