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FDA grants Fast Track designation to Vir Biotechnology's VIR-5500 for late-line prostate cancer
VIRVir Biotechnology, Inc.
The U.S. Food and Drug Administration has 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 (mCRPC). The drug is being co-developed by Vir Biotechnology and Astellas Pharma Inc. through a global strategic collaboration. VIR-5500 is currently evaluated in an open-label Phase 1 study across six dose-expansion cohorts, with pivotal Phase 3 trials anticipated to begin in 2027. Fast Track designation is intended to facilitate and expedite the development and review of drugs treating serious conditions that fill unmet medical needs. Vir Biotechnology is a clinical-stage biopharmaceutical company focused on discovering and developing medicines for serious infectious diseases and cancer.