BMS to Withdraw Istodax for PTCL After Disappointing Confirmatory Trial

Bristol Myers Squibb (BMS) said it plans to withdraw Istodax’s indication as a monotherapy for peripheral T-cell lymphoma (PTCL) after at least one prior therapy.

Istodax (romidepsin), a histone deacetylase inhibitor, was originally developed by Celgene, but became part of BMS’ portfolio when the company bought Celgene in 2019.

The drug had received accelerated approval in 2011 based on cancer clearance data from two single-arm clinical trials. However, Istodax didn’t show statistically significant results in a recent confirmatory phase 3 trial assessing progression-free survival in newly diagnosed patients.

Istodax remains on the market for treatment of patients with cutaneous T-cell lymphoma who have received at least one prior systemic therapy, said the company.