Telix Pharmaceuticals Limited announces that its prostate cancer PET imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in France by ANSM 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-PET imaging represents a significant advancement in prostate cancer management, providing clinicians with more information than conventional imaging methods (bone scan, CT 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 trial^[6]. 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."