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news.Celgene has received Priority Review classification from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for Istodax (romidepsin) for injection.
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Istodax is indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
Celgene said that sNDA filing for Istodax was supported by the safety and efficacy results of a Phase II, multicenter, international, open-label study of Istodax in progressive or relapsed PTCL following prior systemic therapy.
Istodax is not approved as a treatment in progressive or relapsed PTCL.