Cancer NetworkOriginal article
<![CDATA[VIR-5500 Receives FDA Fast Track Designation for Late-Line Metastatic CRPC]]>
RegulatoryVIR-5500Positive
AI Analysis
Summary
VIR-5500, a PSMA-targeted T-cell engager, received FDA Fast Track designation for late-line metastatic CRPC based on clinical data showing 82% PSA50 response rate and 45% ORR at higher doses in heavily pretreated patients.
Clinical Trial Data
Primary Endpoint
Met
Outcome Details
FDA Fast Track Designation granted
Importance:7/10
Sentiment:
0.75
FDA Fast TrackPSMA-targetedT-cell engagermCRPCPSA50 responseORR
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Published by Cancer Network on October 9, 2026 3:00 PM