Pharmaceutical Business review

Celgene obtains FDA priority review for Istodax

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.