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  • The US Food and Drug Administration approves Telix Pharmaceuticals (TLX) prostate cancer imaging product, Illuccix
  • The approval of the product offers improved imaging to detect metastatic prostate cancer and determine the most appropriate treatment pathway for patients 
  • Telix says this marks an important new stage for the company as it brings its first commercial product to market in the US
  • Shares are up 2.79 per cent to $8.11 at 10:34 am AEDT

The US Food and Drug Administration has approved Telix Pharmaceuticals (TLX) prostate cancer imaging product, Illuccix.

The product is a kit for the preparation of an injection used during positron emission tomography (PET) scans of prostate-specific membrane antigen (PSMA) positive lesions in patients who have suspected metastasis and are candidates for initial definitive therapy.

Additionally, it is also assessing patients with prostate cancer that have a suspected recurrence based on the elevated serum prostate-specific antigen level.

The product has already been approved by the Australia Therapeutic Goods Administration, and the company said it improves imaging available to detect metastatic prostate cancer and determine the most appropriate treatment pathway for patients.

It comes as the company prepares to bring its first commercial product to market in the
the United States.

Managing Director and CEO Christian Behrenbruch said this heralds a new era of patient and physician access to gallium-based PSMA-PET imaging.

“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,” Dr Behrenbruch said.

Moreover, Medical Director at the Tulane Cancer Centre, Dr Oliver Sartor said Telix’s product offers a level of flexibility and accessibility to healthcare professionals rarely seen before in this class of products.

With US FDA and Australian TGA approval under its belt, the company is now progressing marketing authorisation applications for Illuccix in the European Union, Canada and other jurisdictions around the globe.

Shares are up 2.79 per cent to $8.11 at 10:34 am AEDT.

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