A decade on from initial approval, Istodax PTCL indication withdrawn

Patients in the USA with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy will no longer be given Istodax (romidepsin).

The histone deacetylase inhibitor was approved by the US Food and Drug Administration (FDA) in 2011 when it was in the portfolio of Celgene, a company which in 2019 became a subsidiary of Bristol Myers Squibb (NYSE: BMY).

This accelerated approval was based on results from two clinical studies, assessing the effect of Istodax on the surrogate endpoint of overall response rate.