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Keytruda's Urothelial Cancer Claim Goes From Accelerated To Full Approval, With More Limited Scope

 
• By Sue Sutter

US FDA showed some regulatory flexibility by relying on longer-term follow-up from Merck’s original single-arm trial, rather than additional confirmatory studies, to retain the first-line claim, but it narrowed the target population to those with the greatest unmet need; Keytruda indication was one of six 'dangling' accelerated approvals re-examined by Oncologic Drugs Advisory Committee in April.

Narrow opening
FDA has narrowed the first-line urothelial carcinoma population for Keytruda. • Source: Alamy

The US Food and Drug Administration opted to rely on longer-term follow-up from Merck & Co., Inc.’s original single-arm trial, rather than additional confirmatory studies, as the basis for converting Keytruda’s (pembrolizumab) accelerated approval in first-line urothelial carcinoma to regular approval.

In the process, the agency narrowed the indication to those patients with the greatest unmet needed.

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