Keytruda's Broad Confirmatory Trials Suggest Evolution Of US FDA’s Accelerated Approval Model
FDA’s most recent accelerated approvals for Merck’s Keytruda call for confirmatory trials in a broader patient population than the approved indications, in the latest example of FDA’s growing comfort with multi-purpose confirmatory trials in the PD-1/PD-L1 inhibitor space.
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Astellas and Seattle Genetics now expect key top-line data on their antibody-drug conjugate in urothelial cancer in the first half of next year, as pivotal trials in support of a planned US accelerated approval progress.
Keeping Track: Keytruda Adds Two New Uses, Furoscix ‘Patch Pump’ Gets A CRL, And Nightstar Nabs An RMAT
The latest drug development news and highlights from our US FDA Performance Tracker.
What We Talk About When We Talk About Confirmatory Evidence
Meaning of 'confirmatory evidence' becomes review issue in some of US FDA's most difficult choices: when a drug for a significant unmet medical need is supported by a single inadequate – but not failed – clinical trial. Neurology division director Dunn and review team leader Marler explain their interpretations in Ocrevus review memos.