Vir Biotechnology Announces PSMA-targeted PRO-XTEN® Dual-masked T-cell Engager VIR-5500 Received FDA Fast Track Designation for the Treatment of Prostate Cancer
The FDA granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN dual-masked T-cell engager, for the treatment of late-line metastatic castration-resistant prostate cancer. VIR-5500 is being co-developed with Astellas Pharma under a global strategic collaboration and is currently in a Phase 1 trial across six dose-expansion cohorts, with earlier data showing promising anti-tumor activity and general tolerability.
Key figures
- Drug Name
- VIR-5500
- Phase Of Trial
- Phase 1
- Indication
- late-line metastatic castration-resistant prostate cancer (mCRPC)
- Designation
- FDA Fast Track
- Phase3 start
- 2027
- Dose expansion cohorts
- 6
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