Celgene Corporation announced that the FDA has granted accelerated approval for its supplemental New Drug Application (sNDA) for an additional indication for Istodax (romidepsin injection): the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. Istodax’s sNDA approval is based on a 6-month priority review by the FDA of results from two studies, including a Phase 2, multicenter, international, open-label, single-arm study of Istodax in patients with PTCL who had failed at least one prior systemic therapy, and a single-arm clinical study of Istodax in patients with PTCL who had failed prior therapy. This indication is based on response rate however clinical benefit such as improvement in overall survival has not been demonstrated.
Istodax for injection is a histone deacetylase (HDAC) inhibitor. Istodax is also approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
For more information call (908) 673-9000 or visit www.celgene.com