OncoMatch/Clinical Trials/Pluvicto

Pluvicto (177Lu-PSMA-617) Clinical Trials

Pluvicto (lutetium Lu 177 vipivotide tetraxetan, 177Lu-PSMA-617) is a radioligand therapy that binds prostate-specific membrane antigen (PSMA) on prostate cancer cells and delivers targeted beta-particle radiation. It was FDA-approved in March 2022 for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) in patients previously treated with androgen-receptor-pathway inhibition and taxane-based chemotherapy, based on the Phase 3 VISION trial, which showed improved overall and radiographic progression-free survival. Eligibility requires PSMA-positive disease confirmed by Locametz (68Ga gozetotide) or another approved PSMA PET product. The PSMAfore trial extended its use earlier in the disease course, leading to a March 2025 FDA label expansion to PSMA-positive mCRPC after an AR-pathway inhibitor in patients considered appropriate to delay taxane chemotherapy. Active trials are evaluating still-earlier settings, combinations, and alpha-emitter PSMA radioligands such as actinium-225 PSMA.