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

 
• By Sue Sutter

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 Claim for second-line peripheral T-cell lymphoma was withdrawn because first-line study failed to meet its progression-free survival endpoint.

Dangling shoes
BMS' decision to withdraw Istodax's PTCL claim means one less accelerated approval indication dangling in the wind. • Source: Alamy

Bristol Myers Squibb Company’s Istodax (romidepsin) is the first anti-cancer drug outside the PD-1/L1 class to lose an accelerated approval indication under the US Food and Drug Administration’s recent initiative to remove “dangling” claims from labeling when confirmatory trials fail.

On 2 August, BMS announced it would withdraw Istodax’s indication for second-line treatment of peripheral T-cell lymphoma (PTCL) because a confirmatory trial in the first-line setting

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