FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication

FDA

28 March 2025 - Today, the FDA expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy.

Patients with previously treated mCRPC should be selected for Pluvicto using Locametz (active ingredient gallium Ga 68 gozetotide) or another approved PSMA positron emission tomography product based on PSMA expression in tumours.

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US