Vir Biotechnology’s VIR‑5500 receives FDA Fast Track designation for late‑line metastatic CRPC
The U.S. Food and Drug Administration granted Fast Track status to VIR‑5500, Vir Biotechnology’s PSMA‑targeted T‑cell engager co‑developed with Astellas Pharma, for treatment of late‑line metastatic castration‑resistant prostate cancer. The company said the designation will enable more frequent FDA interactions and could speed development, with Phase 3 trials slated to begin in 2027. Phase 1 data showed deep PSA reductions and an objective response rate of 45% in heavily pretreated patients.
Why it matters
Vir Biotechnology stated the Fast Track designation should accelerate the drug’s development timeline and may improve the commercial outlook for the product.
Key facts
- 1The FDA granted Fast Track designation to VIR‑5500 for late‑line metastatic CRPC. targetedonc.com
- 2Phase 3 trials are anticipated to begin in 2027. cancernetwork.com
- 3In the Phase 1 trial, 82% (14/17) of PSA‑evaluable patients achieved a ≥50% PSA decline. targetedonc.com
- 453% (9/17) of PSA‑evaluable patients achieved a ≥90% PSA decline. targetedonc.com
- 5The objective response rate was 45% (5/11) among patients with measurable disease. targetedonc.com
- 6Grade 3 or higher treatment‑related adverse events occurred in 12% (7/58) of patients. targetedonc.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.