Telix pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that his prostate cancer PET (1) image-like illustration of Illuccix® (KIT for the production of a Gallium-68-goetid injection) from BASG (2) The approval for evidence and localization of prostate specific Membrane antigen (PSMA)-positive lesions in adults with prostate cancer has received a broad clinical name. This approval enables health service providers in Austria to offer PSMA PET (3) imaging using a clinically validated radiopharmaceutical base based on a gallium.
Illuccix is indicated in Austria after the radio marking with Gallium-68 for the detection of prostate-specific membrane antigen (PSMA)-positive lesions using PET in adults with prostate cancer (PCA) in the following clinical situations:
- Primary staging of patients with high-risk PCA before primary curative therapy.
- Suspected of recurrent PCA in patients with increasing serum values of the prostate -specific antigen (PSA) after primary curative therapy.
- Identification of patients with PSMA-positive progressive metastasized castration-resistant prostate cancer (MCRPC) for which a PSMA-oriented therapy is indicated.
PSMA PET imaging represents significant progress in the treatment of prostate cancer and replaces largely conventional imaging methods (bone scintigraphy, CT (4) scan) as standard procedures according to the initial diagnosis and in the case of biochemical recurrence (BCR). Global guidelines emphasize the superior accuracy of PSMA PET for the stages of the primary disease and the assessment of the BCR/Biochemical Persistence (BCP) (5). Illuccix® PSMA-PET will help to cover a critical, uncovered need by facilitating access to a timely and effective diagnosis and patient selection for treatment with PSMA-oriented therapy.
Professor Dr. Michael Gabriel, Head of the Institute for Nuclear Medicine and Endocrinology at the Kepler University Clinic in Linz and President of the Austrian Society for Nuclear Medicine and Theranostics (OGNT), commented as follows: “PSMA PET imaging has the way we recognize and monitor prostate cancer and offers us an far more accuracy as conventional Methods in Austria.
Illuccix’s wide approval is based on solid clinical data, including the largest GA-68-based PSMA data set from the vision study (6).
Raphaël Ortiz, Managing Director, Telix International, commented: “The admission of Illuccix in Austria expands access to PSMA PET imaging and supports the clinicians in carrying out precision oncology for men with prostate cancer. With our innovative radiopharmaceutical portfolio and through our sales partner THP Medical Products, we want to enable better-informed treatment decisions. We look forward to working with health service providers to ensure that more patients can benefit from this advanced imaging solution. “
Illuccix will be available in Austria via the Telix sales partner THP Medical Products, a specialized provider and distributor of nuclear medicine products and services. In order to order Illuccix or to find out more about availability, authorized medical specialists in Austria can send an email to orders.nuk@thp.at Or call at +43 1 292 82 80.
Prostate cancer in Austria
With more than 5,900 new cases per year, prostate cancer is the most common cancer in men in Austria and has a significantly higher incidence than colon cancer (2,616 new cases) or lung cancer (3,004 new cases). Prostate cancer is the second most common cause of cancer in men in Austria. In 2022, over 1,300 men died of this disease (7).
Information on Illuccix
The prostate image product of Telix, Gallium-68 (68GA) Gozetotide injection (also known as 68GA PSMA-11 and markets under the brand name Illuccix®), was by the US Food and Drug Administration (8), by the Australian Therapeutic Goods Administration (TGA) (9), of) Health Canada (10), through the British Medicines and Healthcare Products Regulatory Agency (11) (11), approved by the Brazilian health authority (ANVISA) (12), and in several Member States of the European Economic Area (EEA) (13). Illuccix® is currently in the national approval test in other countries of the EEA after the BfArM has given a positive opinion in the decentralized procedure (DCP) (14).
Information on Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company that focuses on the development and marketing of therapeutic and diagnostic radiopharmaceuticals and the associated medical technologies. Telix has its headquarters in Melbourne, Australia, and maintains international branches in the USA, Brazil, Canada, Europe (Belgium and Switzerland) and Japan. Telix is developing a portfolio of products in clinical and commercial stage that aims at a significant, uncovered medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX).
Visit www.telixpharma.comto obtain further information about Telix, including details on the current share price, ASX and SEC submissions, investor and analyst presentations, press releases, details on events and other publications that could be of interest. You can also use Telix LinkedIn, X and Facebook consequences.
Telix Investor Relations
Fr. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communication
E-mail: kyahn.williamson@telixpharma.com
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(1) Positronen-Emissions-Tomographie. (2) Österreichisches Bundesamt für Sicherheit im Gesundheitswesen. (3) Bildgebung von prostataspezifischem Membranantigen mit Positronenemissionstomographie. (4) Computertomographie. (5) EAU-Leitlinien. Auflage präsentiert auf dem EAU-Jahreskongress Paris 2024. ISBN 978-94-92671-23-3: https://uroweb.org/guidelines/prostate-cancer ; Prostatakrebs: ESMO-Leitlinien für die klinische Praxis zur Diagnose, Behandlung und Nachsorge. 2023: https://www.esmo.org/guidel ines/guidelines-by-topic/esmo-clinical-practice-guidelines-genitourinary-cancers/clinical-practice -guidelines-prostate-cancer/eupdate-prostate-cancer-treatment-recommendations (6) ClinicalTrials.gov ID: https://clinicaltrials.gov/study/NCT03511664 . VISION-Studie, gesponsert von Endocyte, einem Unternehmen von Novartis. Telix stellte Illuccix (TLX591-CDx) für die PSMA-PET-Bildgebung zur Verfügung. (7) Globale Krebsstatistik 2022: GLOBOCAN-Umfrage. Veröffentlicht im August 2024. (8) Telix ASX Offenlegung 20. Dezember 2021. (9) Telix ASX Offenlegung 2. November 2021. (10) Telix ASX Offenlegung 14. Oktober 2022. (11) Telix ASX Offenlegung 13. Februar 2025. (12) Telix ASX Offenlegung 18. März 2025. (13) Frankreich, Schweden, Deutschland, Portugal, Griechenland, Tschechische Republik, Belgien, Italien, Österreich, Dänemark, Irland, Luxemburg, Malta, Niederlande, Norwegen und Schweden zum Zeitpunkt der Veröffentlichung. (14) Das deutsche Bundesinstitut für Arzneimittel und Medizinprodukte. Telix ASX Offenlegung 17. Januar 2025.
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