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Pazdur’s Post-Mortem On ‘Dangling’ Accelerated Approvals: Message At ODAC Was Heard Loud And Clear

 
• By Kate Rawson

The three-day advisory committee was intended to ‘put companies on notice’ about the importance of confirmatory trials. The result? Mission accomplished.

loudspeakers (Alamy)
• Source: Alamy

The immediate impact of the US Food & Drug Administration’s oncology advisory committee’s consideration of six “dangling” Accelerated Approvals in the PD-1 class – and the underlying message that FDA was getting serious about AA drugs that had failed confirmatory studies – was for a sponsor to volunteer to remove an indication from the market.

“I was shocked,” Oncology Center of Excellence and Director Rick Pazdur said during an 8 June interview with Prevision...

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