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# Novartis Wins Expanded Pluvicto Use in Prostate Cancer
- URL: https://www.fdaweb.com/novartis-wins-expanded-pluvicto-use-in-prostate-cancer/
- Published: 2025-03-28T12:00:00.000Z
- Updated: 2026-09-14T14:56:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158914

FDA has approved a Novartis supplemental NDA to expand the indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) 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 (ARPI) therapy and are delaying taxane-based chemotherapy. Previously, the radioligand therapeutic agent was approved for the same indication, but in those who were also treated with 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 (PET) product based on PSMA expression in tumors,” an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication?ref=fdaweb.com) says.

Expanded approval is based on data from PSMAfore (NCT04689828), a randomized trial enrolling 468 patients. Radiographic progression-free survival was 9.3 months in the lutetium Lu 177 vipivotide tetraxetan arm and 5.6 months in the ARPI arm, FDA says. Median overall survival was 24.5 months and 23.1 months in the respective arms, it says, adding that adverse reactions were consistent with prior experience with lutetium Lu 177 vipivotide tetraxetan.