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# FDA Approves Novartis’ Pluvicto for Prostate Cancer
- URL: https://www.fdaweb.com/fda-approves-novartis-pluvicto-for-prostate-cancer/
- Published: 2022-03-24T12:00:00.000Z
- Updated: 2026-09-14T17:37:55.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5151443

FDA approved 3/23 Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. An agency [notice](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer?ref=fdaweb.com) says concurrent approval was granted for the company’s Locametz (gallium Ga 68 gozetotide), a radioactive diagnostic agent for positron emission tomography of PSMA-positive lesions, including the selection of patients with metastatic prostate cancer for whom Pluvicto therapy is indicated. FDA says Locametz is the first radioactive diagnostic agent approved for patient selection in the use of a radioligand therapeutic agent.

Pluvicto efficacy was evaluated in the VISION trial that FDA says demonstrated a statistically significant improvement in the primary endpoints of overall survival and radiographic progression-free survival.

The notice says the most common adverse reactions to Pluvicto were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation.

The agency review used the Assessment Aid, a voluntary submission from Novartis to facilitate the agency’s assessment. The application had been granted priority review and breakthrough designation.