TLX Telix Pharmaceuticals Ltd

EAU Updates Guidance for PSMA-PET Imaging
Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) welcomes the updated 2022 ‘Guidelines on Prostate Cancer’ (the Guidelines) from the European Association of Urology (EAU), which demonstrate an increasing recognition of the clinical utility of prostate specific membrane antigen (PSMA) positron emission tomography (PET) imaging modalities (PSMA PET), including gallium-68 PSMA-11, in the diagnosis of prostate cancer.1

The EAU Guidelines are dedicated to the development of clinical best practice for frontline urologists and to support shared decision making with patients, underpinning a shift towards more individualised patient care.

The EAU Guidelines recognise PSMA PET/CT as more accurate than CT and bone scan for the staging of high-risk prostate cancer, based on clinical data. Despite the increased sensitivity, the Guidelines acknowledge the lack of outcome data of subsequent treatment changes when using PSMA PET or whole-body MRI. The Guidelines further recommend lutetium-based PSMA therapy be offered to pre-treated metastatic castrate resistant prostate cancer (mCRPC) patients with one or more metastatic lesions, highly expressing PSMA (exceeding the uptake in the liver) on the diagnostic radiolabelled PSMA PET/CT scan.

Prof. Stefano Fanti, Director of Nuclear Medicine at the University of Bologna, said “The updated EAU Guidelines recognise that PSMA-PET imaging is more accurate than conventional imaging methods in prostate cancer initial staging, for high-risk disease. As opposed to NCCN,2 the EAU Guidelines underline the lack of outcome data of subsequent PSMA-PET treatment change. It sends a clear message of our quest for increased robustness and homogeneity in trials including PSMA-PET.”

Dr Colin Hayward, Telix Chief Medical Officer added “We are pleased the EAU continues to lead urology standards in Europe, acknowledging the importance of PSMA as a target, for improving sensitivity in assessing prostate cancer.

“We are focused on ensuring PSMA-PET imaging is widely available for patients across Europe, as we work towards European Marketing Authorisation Approvals for llluccix®.

“With Telix making PSMA PET more broadly available as we achieve approval in various markets, we look forward to contributing to the knowledge base around treatment changes based on PSMA PET.”

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation 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). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

Telix’s lead product, Illuccix® (kit for preparation of gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection) for prostate cancer imaging, has been approved by the U.S. Food and Drug Administration (FDA),3 and by the Australian Therapeutic Goods Administration (TGA).4 Telix is also progressing marketing authorisation applications for this investigational candidate in Europe5 and Canada.6

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com

This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.

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1 European Association of Urology (EAU) Guidelines on Prostate Cancer. Limited Update March 2022. Available at: https://uroweb.org/guidelines/prostate-cancer.2 National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Sep 2021. Available at: https://www.nccn.org/guidelines/category_1.3 ASX disclosure 20 December 2021.4 ASX disclosure 2 November 2021.5 ASX disclosure 10 December 2021.6 ASX disclosure 16 December 2020.