Telix's Illuccix PSMA-PET Imaging Agent Approved in France

Rhea-AI Summary

Telix Pharmaceuticals has received marketing authorization in France for Illuccix, its prostate cancer PET imaging agent. The approval by ANSM enables French healthcare facilities to access this PSMA-PET imaging technology for prostate cancer detection and management.

The approval covers three key clinical applications:

• Primary staging of high-risk prostate cancer patients
• Detection of recurrent cancer in patients with rising PSA levels
• Identification of patients suitable for PSMA-targeted therapy

Telix has partnered with IRE ELiT for marketing and promotion in France, where prostate cancer affects over 57,000 new cases annually. The technology offers superior accuracy compared to conventional imaging methods and allows on-site preparation of PSMA-PET scans, improving accessibility and reducing diagnosis delays.

Positive

• Marketing authorization granted in France for Illuccix PSMA-PET imaging agent, expanding market reach
• Broad clinical label approval covering multiple prostate cancer stages and use cases
• Strategic partnership with IRE ELiT for marketing and distribution in France
• Large addressable market with over 57,000 new prostate cancer cases annually in France
• Product offers on-site preparation capability for hospitals, improving accessibility and workflow efficiency

Negative

• None.

Insights

Pharmaceutical Industry Analyst

Telix secures French approval for Illuccix, expanding into a major prostate cancer market with 57,000 annual diagnoses.

Telix Pharmaceuticals has secured marketing authorization from France's regulatory agency ANSM for Illuccix, its prostate cancer PET imaging agent. This approval represents a significant commercial milestone in the company's European expansion strategy.

The French authorization includes a broad clinical label covering multiple applications: primary staging of high-risk prostate cancer, detection of recurrent cancer, and identification of patients suitable for PSMA-targeted therapy. This comprehensive labeling maximizes the product's clinical utility across the patient journey.

The approval addresses a substantial market opportunity. Prostate cancer is the most common cancer in men in France, with over 57,000 new cases diagnosed annually - significantly higher than lung cancer (32,800) and bowel cancer (27,000). The country also records 9,200 prostate cancer deaths yearly.

Illuccix's on-site preparation capability offers a practical solution to accessibility challenges in French healthcare institutions. By enabling hospitals to prepare scans on-site, Telix overcomes logistical barriers that have limited PSMA-PET imaging availability.

Strategically, Telix has partnered with IRE ELiT S.A., a radiopharmaceutical specialist, for marketing and promotion to French healthcare professionals. This collaboration leverages local expertise and establishes a dedicated distribution channel in this key European market.

Medical Imaging Specialist

Illuccix brings advanced PSMA-PET technology to French clinicians, addressing significant diagnostic gaps in prostate cancer management.

The approval of Illuccix introduces clinically validated PSMA-PET imaging technology to the French healthcare system. This represents a diagnostic advancement over conventional imaging methods like bone scans and CT scans by providing more detailed visualization of prostate cancer lesions.

The technology's clinical value centers on its superior accuracy in multiple scenarios - from initial staging of high-risk disease to biochemical recurrence detection. Global guidelines already recognize PSMA-PET's advantages, and this approval aligns French diagnostic capabilities with international standards of care.

From a workflow perspective, Illuccix's formulation using generator-produced gallium offers significant practical advantages. By enabling on-site preparation, the product integrates into existing hospital workflows, potentially reducing waiting times and improving operational efficiency in nuclear medicine departments.

The product is supported by robust scientific evidence from the VISION trial, representing the largest Ga-68-based PSMA data set. This strong clinical foundation strengthens the product's positioning within evidence-based medicine frameworks.

For French oncology departments like the University Cancer Institute of Toulouse, as referenced by Professor Frédéric Courbon, this approval provides a solution for what has been described as "equitable and reliable access to PSMA-PET" - potentially reducing diagnostic delays and improving patient management pathways.

New approval provides French hospitals and clinics with access to a proven PSMA-PET imaging agent

MELBOURNE, Australia, April 29, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that its prostate cancer PET¹ imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in France by ANSM² for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label.

Illuccix, after radiolabelling with gallium-68, is indicated in France for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy. Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.

PSMA-PET³ imaging represents a significant advancement in prostate cancer management, providing clinicians with more information than conventional imaging methods (bone scan, CT⁴ scan) thereby offering a new standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognise its superior accuracy in staging primary disease and assessing BCR/biochemical persistence (BCP)⁵. Illuccix® PSMA-PET will help address an important clinical need by supporting timely and effective diagnosis, as well as identifying patients who may benefit from PSMA-targeted therapy.

Illuccix’s broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial⁶. The approval of Illuccix® in France has the potential to resolve access challenges by enabling hospitals and clinics to prepare PSMA-PET scans on-site, offering physicians a quicker, more accessible solution.

Professor Frédéric Courbon, Head of the Medical Imaging Department - University Cancer Institute of Toulouse – Oncopole, commented, “PSMA-PET imaging is dramatically changing prostate cancer patient management. Thus, equitable and reliable access to PSMA-PET across France is essential. The approval of Illuccix® in France will address some of the access challenges, and reduce the risk of delayed diagnosis, with a readily available option for effective disease management."

With its broad indication and ready-to-use formulation, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow across Europe, reinforcing the need for solutions that fit within existing hospital workflows.

“The approval of Illuccix in France will enable a clinically validated PSMA-PET product to be more widely available, allowing healthcare providers to benefit from the convenience and flexibility of generator-produced gallium. This milestone reinforces our ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic technologies across Europe,” said Raphaël Ortiz, Chief Executive Officer, Telix International.

Telix will partner with IRE ELiT S.A. (the radiopharmaceutical subsidiary of IRE Group), a leading provider of radioisotopes and radiopharmaceuticals for nuclear medicine, for the marketing and promotion of Illuccix® to healthcare professionals in France.

Jean Bonnet, Head of Strategy, Sales and Marketing, IRE EliT added: "We are pleased to collaborate with Telix and bring our expertise to expanding the availability of Illuccix throughout France. We are committed to ensuring that clinicians have access to reliable PSMA-PET imaging technologies to improve the lives of people living with prostate cancer."

Notes to editors

• French healthcare professionals interested in ordering Illuccix® or learning more about availability can contact Eric Rizzo: eric.rizzo@ire-elit.eu
  

Prostate Cancer in France

Prostate cancer is the most common cancer in men in France, with over 57,000 new cases diagnosed annually, and a significantly higher incidence in men than either lung cancer (32,800 new cases) or bowel cancer (27,000 new cases). Prostate cancer is also a common cause of cancer death in men, with over 9,200 men dying from their disease in France in 2022⁷.

About Illuccix®

Telix’s prostate imaging product, gallium-68 (⁶⁸Ga) gozetotide injection (also known as ⁶⁸Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)⁸, by the Australian Therapeutic Goods Administration (TGA)⁹, by Health Canada¹⁰, by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)¹¹, by the French ANSM, and in multiple other European Economic Area (EEA) Member States¹². Illuccix® is currently in national approval review across the European Economic Area following a positive decentralized procedure (DCP) opinion by BfArM¹³.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Telix’s osteomyelitis (bone infection) imaging agent, technetium-99m (^99mTc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix’s miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Legal Notices

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

©2025 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country.

---

¹ Positron emission tomography.
² National Agency for the Safety of Medicine and Health Products (Agence nationale de sécurité du médicament et des produits de santé).
³ Imaging of prostate-specific membrane antigen with positron emission tomography.
⁴ Computed tomography.
⁵ European Association of Urology (EAU) Guidelines. Edn. presented at the EAU Annual Congress Paris 2024. ISBN 978-94-92671-23-3.: https://uroweb.org/guidelines/prostate-cancer; Prostate cancer: European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for diagnosis, treatment and follow-up. 2023: https://www.esmo.org/guidelines/guidelines-by-topic/esmo-clinical-practice-guidelines-genitourinary-cancers/clinical-practice-guidelines-prostate-cancer/eupdate-prostate-cancer-treatment-recommendations
⁶ ClinicalTrials.gov ID: NCT03511664. VISION study sponsored by Endocyte, a Novartis company. Telix provided Illuccix® (TLX591-CDx) for PSMA-PET imaging.
⁷ Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.
⁸ Telix ASX disclosure 20 December 2021.
⁹ Telix ASX disclosure 2 November 2021.
¹⁰ Telix ASX disclosure 14 October 2022.
¹¹ Telix ASX disclosure 13 February 2025.
¹² Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release.
¹³ The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). Telix ASX disclosure 17 January 2025.

FAQ

What is Telix's Illuccix PSMA-PET imaging agent approved for in France 2025?

Illuccix is approved in France for detecting PSMA-positive lesions in adults with prostate cancer in three key areas: primary staging of high-risk prostate cancer, monitoring PSA level increases after treatment, and identifying patients suitable for PSMA-targeted therapy in metastatic cases.

How will Telix (TLX) distribute Illuccix in the French market?

Telix will partner with IRE ELiT S.A., a leading radioisotope provider, to market and promote Illuccix to healthcare professionals across France. French healthcare professionals can contact Eric Rizzo at IRE ELiT for ordering information.

What is the market size for Telix's Illuccix in France?

France represents a significant market with over 57,000 new prostate cancer cases annually, substantially higher than lung cancer (32,800 cases) and bowel cancer (27,000 cases). The country records approximately 9,200 prostate cancer deaths yearly.

What advantages does Illuccix PSMA-PET imaging offer over traditional methods?

Illuccix PSMA-PET imaging provides more detailed information than conventional imaging methods like bone and CT scans. It offers superior accuracy in staging primary disease and assessing biochemical recurrence, supporting faster and more effective diagnosis.

How will French hospitals benefit from Telix's Illuccix approval?

The approval enables French hospitals and clinics to prepare PSMA-PET scans on-site, offering a quicker and more accessible diagnostic solution. This helps resolve access challenges and reduces the risk of delayed diagnosis in prostate cancer management.