TGA grants priority review status to Telix’s (ASX:TLX) application for TLX591-CDx

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TGA grants priority review status to Telix’s (ASX:TLX) application for TLX591-CDx

 TGA grants priority review status to Telix’s (ASX:TLX) application for TLX591-CDx

Image Source: Shutterstock


  • Telix Pharmaceuticals announced that its application for TGA determination received priority review status.
  • This status means an acceleration in product review as well as approval timeframe.
  • There is a significant opportunity for Telix in Australia’s prostate cancer market with an estimated 90k patients in the country at present.

Melbourne-headquartered Telix Pharmaceuticals Limited (ASX:TLX) announced today that the Company received a priority review status from the Australian TGA for its prostate cancer imaging product, TLX-591-CDx (68Ga-PSMA-11).

Let us look at the business Telix is into and its latest announcement in detail:

About Telix Pharmaceuticals

Australian biotech Company biopharmaceutical works in the field of development of therapeutic and diagnostic goods that use Molecular Targeted Radiation technique. The Company is focused on addressing the unmet need in the area of oncology, specifically, renal cancer, prostate cancer, and brain cancer.

Priority Review status for TLX591-CDx

As highlighted above, the priority review status by the TGA gives an accelerated time frame to Telix for dossier review and approval. The granted time frame is 150 working days.

The initial application for TLX591-CDx to the TGA was made around the same time as its NDA application to the US Food and Drug Administration. Notably, it was the first commercial PSMA imaging NDA submission in the US. This was a significant achievement for the Company following the Europe submission back in April.

Besides, there is a Medical Services Advisory Committee application already underway. Telix is of the view that by the time this approval arrives around May-June 2021, it would coincide with the product’s commercial availability, depending on TGA approval post review.

             Image Source: Shutterstock

Australian Cancer Statistics

According to Cancer Australia, prostate cancer is the most diagnosed form of cancer (19k+ cases a year) and is the 2nd most common cause of mortality in Australian males with over 3,000 casualties per year. Nearly 90,000 Australians are prostate cancer patients.

DO READ: What fuelled Telix Pharmaceuticals' (ASX:TLX) rally this week?

Management Commentary

Dr. Chris BehrenBruch, the CEO of Telix, stated:

About TLX-591-CDx (68Ga-PSMA-11)

TLX-591-CDx (68Ga-PSMA-11), the prostate cancer screening product by Telix, is currently in use in Australia, the US, and Europe under investigation and clinical trial. It is also being tried in several other countries. Ideally befitting for radiolabelling, at high production consistency and high radiochemical purity at room temperature, it is most suited for hospital and other commercial settings.

Though the product has not received marketing rights in any country yet, the firm hopes to move in that direction once the approvals have arrived.

TLS shares ended the day’s trading session at A$3.830, a decline of 3.038%.


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