> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Telix sNDA Approved for Illuccix Selection
- URL: https://www.fdaweb.com/telix-snda-approved-for-illuccix-selection/
- Published: 2023-03-16T12:00:00.000Z
- Updated: 2026-09-14T18:19:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153997

FDA has approved a Telix Pharmaceuticals supplemental NDA for Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) for use in selecting patients with metastatic prostate cancer for whom Novartis’ Pluvicto is indicated. To qualify to be treated with the prostate-specific membrane antigen (PSMA)-directed radioligand Pluvicto, patients must be imaged with an approved gallium-based PSMA-PET agent such as Illuccix, Telix says.

Approval was based on data from the VISION Phase 3 study that demonstrated Illuccix “helped doctors detect prostate cancer and identify the appropriate patients for PSMA-based radioligand therapy,” Telix )says. About 32,000 patients per year in the U.S. may be considered for PSMA-directed radioligand therapy, it adds.