Istodax’s Lymphoma Accelerated Approval Indication Falls Victim To Failed Confirmatory Trial

BMS’ histone deacetylase inhibitor is the first oncology drug outside the PD-1/L1 class to lose an indication under US FDA’s recent review of ‘dangling’ accelerated approvals. Claim for second-line peripheral T-cell lymphoma was withdrawn because first-line study failed to meet its progression-free survival endpoint.