Bristol Myers Squibb has decided to withdraw the indication for Istodax® (romidepsin) as monotherapy for the treatment of peripheral T-cell lymphoma (PTCL) in adults who have received at least 1 prior therapy.
In 2011, the FDA granted accelerated approval to Istodax, a histone deacetylase inhibitor, for PTCL based on overall response rate from 2 clinical studies. According to the Agency’s accelerated approval program, a drug may be approved earlier if it is intended to treat a serious condition or fills an unmet need; the approval is based on a surrogate end point that is thought to predict clinical benefit.
However, results from a subsequent confirmatory phase 3 study (ClinicalTrials.gov Identifier: NCT01796002) showed that treatment with Istodax plus cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) did not meet the primary efficacy endpoint of progression free survival in previously untreated PTCL patients when compared with CHOP alone.
Bristol Myers Squibb is notifying health care professionals regarding the withdrawal. Patients with PTCL who are being treated with Istodax should consult with their health care provider. The decision to withdraw the PTCL indication does not affect the indication for Istodax for cutaneous T-cell lymphoma in patients who have received at least 1 prior systemic therapy.
“While 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,” said Noah Berkowitz, MD, PhD, senior vice president, Hematology Development, Bristol Myers Squibb.
Bristol Myers Squibb statement on Istodax® (romidepsin) relapsed/refractory peripheral T-cell lymphoma U.S. indication. News release. Bristol Myers Squibb. Accessed August 3, 2021. https://news.bms.com/news/details/2021/Bristol-Myers-Squibb-Statement-on-Istodax-romidepsin-Relapsed-Refractory-Peripheral-T-cell-Lymphoma-U.S.-Indication/default.aspx.