Real-Time Oncology Review Speeds Supplements At US FDA, But Gives Modest Benefit For Novel Agents

 
• By Bridget Silverman
  
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US FDA’s 72 approvals under streamlined submission program consistently come before the PDUFA goal date, Pink Sheet analysis shows, but benefit ranges from 2 weeks for priority review novel agents to 1.8 months for other priority applications.

Fast Stream
RTOR has produced a steady stream of fast approvals. • Source: Shutterstock

The US FDA’s latest approvals under the popular Real-Time Oncology Review (RTOR) program present extreme examples of the pilot initiative’s effect on review times, from the astonishingly quick (a Keytruda/Padcev combination cleared five weeks after submission) to the rare missed user fee goal date (US WorldMeds, LLC’s Iwilfin, approved 6.7 months after its priority goal date, following advisory committee review).

Using our US FDA Performance Tracker’s User Fee Goal Dates chart, the Pink Sheet identified 72 approvals under the RTOR...

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