3 August 2021 - In 2011, Celgene, now a wholly owned subsidiary of Bristol Myers Squibb, received accelerated approval by the U.S. FDA for Istodax (romidepsin), a histone deacetylase inhibitor, as monotherapy for the treatment of 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 effect of Istodax on the surrogate endpoint of overall response rate. 

Bristol Myers Squibb conducted a subsequent confirmatory Phase 3 study evaluating romidepsin plus CHOP (Ro-CHOP) versus CHOP in first-line peripheral T-cell lymphoma patients, but the trial did not meet the primary efficacy outcome of progression free survival.

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