BMS statement on Istodax for relapsed/refractory peripheral T-cell lymphoma FDA Indication
In 2011, Celgene Corporation, now a wholly owned subsidiary of Bristol Myers Squibb, received accelerated approval by the FDA for Istoda (romidepsin), a histone deacetylase (HDAC) inhibitor, as monotherapy for the treatment of peripheral T-cell lymphoma (PTCL) 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 III study evaluating romidepsin plus CHOP (Ro-CHOP) versus CHOP in first-line PTCL patients, but the trial did not meet the primary efficacy endpoint of progression free survival. Based on this outcome, Bristol Myers Squibb made the decision to withdraw the PTCL indication from the U.S. market. The company took this action in accordance with the FDA’s requirements for evaluating accelerated approvals that have not demonstrated sufficient clinical benefit.
Bristol Myers Squibb is notifying healthcare professionals about the withdrawal. Istodax remains on the market for treatment of patients with cutaneous T-cell lymphoma (CTCL) who have received at least one prior systemic therapy. Patients who are being treated with Istodax for PTCL should consult with their healthcare provider in all aspects of their medical care and may remain on treatment if deemed clinically appropriate by the treating physician. For patients who are currently being treated with Istodax for PTCL.