Vir Biotechnology's VIR-5500 wins FDA Fast Track in late-line mCRPC; Phase 3 set for 2027

Vir Biotechnology, Inc.

FDA granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN dual-masked T-cell engager, for late-line metastatic castration-resistant prostate cancer (mCRPC).
VIR-5500 is co-developed with Astellas Pharma Inc. under a global strategic collaboration; pivotal Phase 3 development is anticipated to begin in 2027.
Phase 1 study spans six dose-expansion cohorts: monotherapy in taxane-naive, radioligand therapy-naive and radioligand-exposed mCRPC.
Combination cohorts test VIR-5500 with enzalutamide or docetaxel in early-line mCRPC, and with darolutamide in metastatic hormone-sensitive prostate cancer (mHSPC).
Earlier 2026 Phase 1 data showed VIR-5500 was generally well tolerated with promising anti-tumor activity in mCRPC patients, per CEO Marianne De Backer.

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