Bristol Myers Squibb withdraws peripheral T-cell lymphoma indication for romidepsin
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Bristol Myers Squibb withdrew the indication for romidepsin as treatment for relapsed or refractory peripheral T-cell lymphoma.
Romidepsin (Istodax, Bristol Myers Squibb) is a histone deacetylase inhibitor.
The FDA granted accelerated approval to romidepsin in 2011 as monotherapy for treatment of adults with peripheral T-cell lymphoma who received at least one prior therapy.
The agency based the accelerated approval on results of two studies that assessed romidepsin’s effect on overall response rate, a surrogate endpoint.
A confirmatory phase 3 study evaluated the addition of romidepsin to CHOP as first-line treatment for peripheral T-cell lymphoma. As Healio previously reported, that trial failed to meet its primary efficacy endpoint of PFS.
Bristol Myers Squibb subsequently withdrew the peripheral T-cell lymphoma indication in accordance with FDA requirements for evaluating accelerated approvals that have not demonstrated sufficient clinical benefit.
The decision does not affect romidepsin’s indication for treatment of patients with cutaneous T-cell lymphoma who received at least one prior systemic therapy.
“[Although] the outcome of the confirmatory study in peripheral T-cell lymphoma is disappointing, Bristol Myers Squibb will continue to provide Istodax for patients with cutaneous T-cell lymphoma, where it remains an approved and important treatment option,” Noah Berkowitz, MD, PhD, senior vice president of the hematology department with Bristol Myers Squibb, said in a company-issued press release. “As always, our efforts across blood cancer research and development remain centered on delivering better outcomes for patients in need.”
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