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# Istodax Indication Withdrawn After Confirmatory Trial
- URL: https://www.fdaweb.com/istodax-indication-withdrawn-after-confirmatory-trial/
- Published: 2021-08-03T12:00:00.000Z
- Updated: 2026-09-14T17:09:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149853

Bristol Myers Squibb has announced its decision to withdraw a 2011 indication granted to subsidiary Celgene under accelerated approval for Istodax (romidepsin), a histone deacetylase inhibitor, as monotherapy for treating peripheral T-cell lymphoma in adult patients who have received at least one prior therapy. This accelerated approval was based upon results from two clinical studies, assessing the therapy’s effect on the surrogate endpoint of overall response rate. The decision to withdraw the indication follows a required confirmatory Phase 3 study that failed to meet the primary efficacy endpoint of progression free survival, the company says. Istodax remains approved for treating patients with cutaneous T-cell lymphoma who have received at least one prior systemic therapy.