The U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for Telix Pharmaceuticals’ TLX007-CDx (Gozellix) for prostate cancer imaging.
Gozellix is a kit for preparing gallium-68 gozetotide injection for PET imaging in men with prostate specific membrane antigen (PSMA)-positive lesions and suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level, according to the firm.
At the time of its NDA application, the Melbourne, Australia-based firm planned to target underserved populations across the U.S. through its established nuclear pharmacy distribution partnerships and experience. In addition, the PSMA-PET imaging preparation cold kit is designed to facilitate more flexible production, including with Ga-68 sourced from both newer high-activity generators and cyclotrons.
In its March 21 announcement, the firm highlighted the kit’s longer shelf life of up to six hours and extended distribution radius compared with existing gallium-based imaging products and said it expects Gozellix to be eligible for full reimbursement with reduced or no patient co-insurance. Gozellix will be available alongside Telix’s PSMA-PET imaging agent, Illuccix, the firm said.