“This heralds a new era of patient and physician access to gallium-based PSMA-PET imaging and marks an important new stage for Telix as we bring our first commercial product to market in the United States,” said Dr. Christian Behrenbruch, Managing Director and CEO at Telix. “Improved imaging can provide physicians with the insights to determine the most appropriate treatment pathway and give patients in the U.S. access to a specific and sensitive imaging tool for the detection of prostate cancer throughout the body.”


About Illuccix

Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection.

68Ga gozetotide Injection is used for imaging prostate cancer with positron emission tomography (PET), and targets prostate specific membrane antigen (PSMA), a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Illuccix enables gozetotide (PSMA-11) to be labelled with the radionuclide 68Ga directly before injection by medical professionals. After preparing the radiopharmaceutical and injecting it into the patient, PSMA positive lesions are localized by PET imaging.

Illuccix has been approved by the U.S. Food and Drug Administration (FDA), and by the Australian Therapeutic Goods Administration (TGA). 2 Telix is also progressing marketing authorization applications for Illuccix in the European Union3, Canada4, and other jurisdictions around the globe.


About Prostate Cancer in the United States
Prostate cancer is the second leading cancer in men in the United States after skin cancer, with nearly 250,000 cases estimated in 2021, a significantly higher incidence than either lung cancer (119,000 new cases) or bowel cancer (80,000 new cases). Prostate cancer was also the second leading cause of cancer death in U.S. men in 2020, and it is estimated that more than 34,000 men will die from their disease in 2021.5 More than 812,000 U.S. men were estimated to be living with prostate cancer in 2020.6 In 2021 the National Comprehensive Cancer Network Guidelines® for prostate cancer were updated to include PSMA-PET imaging to be considered as an alternative to standard imaging of bone and soft tissue and for detection of unfavorable intermediate, high and very high risk as well as recurrent prostate cancer.


About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

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