NEW YORK – The US Food and Drug Administration on Friday approved Telix's PSMA-PET prostate cancer imaging agent Gozellix (gallium-68 gozetotide injection) to identify PSMA-positive prostate cancer lesions in certain patients.
The imaging agent is intended for prostate cancer patients who have suspected metastasis and are candidates for initial definitive therapy and for those with suspected recurrence based on elevated serum prostate-specific antigen level.
The agent is a second-generation PSMA-PET imaging agent from Telix. In 2021, the FDA approved the firm's first-generation PSMA diagnostic, Illuccix (68Ga-PSMA-11 injection), for the same patient population. Illuccix expanded its indication in the US in 2023 to include PSMA-positive prostate cancer patient selection for treatment with Novartis' radiopharmaceutical treatment Pluvicto (lutetium Lu 177 vipivotide tetraxetan).
Telix said Gozellix provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products, allowing for better access to the agent farther from its point of production.
Melbourne, Australia-based Telix is also developing two prostate cancer radiotherapy agents for PSMA-positive prostate cancer, one based on lutetium-177 and another on actinium-225. The firm's pipeline also includes radiopharmaceutical diagnostic and therapeutic agents for kidney cancer, glioma, and musculoskeletal cancers.