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news.The US Food and Drug Administration (FDA) has approved Celgene's supplemental new drug application (sNDA) for an additional indication of Istodax (romidepsin) for injection.
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Istodax is an epigenetic therapy and a member of a class of cancer drugs known as histone deacetylase (HDAC) inhibitors.
The approval has been granted for the product to be used as a treatment for the patients with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy.
The FDA approval was supported by the results from two studies which include a Phase II trial which evaluated Istodax in patients with PTCL who had failed at least one prior systemic therapy (Study 3).
The second study was a single-arm clinical study of Istodax in patients with PTCL who had failed prior therapy (Study 4).
Istodax is also indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.