FDA withdraws one of BMS chemo drug indications

May 9, 2022

The U.S. FDA announced it withdrew the new drug application approval for Celgene’s — a Bristol-Myers Squibb Company — cancer drug. Teva Pharmaceuticals’ version is in the same boat.

While the formal decision was just recently announced, the companies had requested that the administration withdraw approval for one indication last year.  

The saga actually started back in August of 2020, when Celgene submitted clinical trial results indicating the study failed to meet its primary endpoint of progression-free survival. The trial, Ro-CHOP,  compared the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL). On May 14, 2021, Celgene informed FDA that after careful consideration, it had decided to voluntarily withdraw the PTCL indication from Istodax (romidepsin) for injection.

The FDA approved an additional indication for Celgene's NDA for Istodax specifically for the treatment of PTCL back in June 2011. The accelerated approval for PTCL included the required postmarketing clinical trial.

The drug is a histone deacetylase inhibitor antineoplastic agent used as a chemotherapy regimen for T-cell lymphoma affecting the skin. Specifically, the drug was given to patients who had been already treated for their cancer with other therapies. Istodax worked by inhibiting histone deacetylases, which act as on and off switches for genes. Its effects helped regulate cell growth and death, the biological processes responsible for tumor formation and spread.