Telix Pharmaceuticals has announced the approval of its prostate cancer imaging agent, Illuccix, by French health authority Agence nationale de sécurité du médicament et des produits de santé (ANSM).
The marketing authorisation allows the preparation of gallium-68 gozetotide injection-based Illuccix for detecting prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer.
This approval covers a wide range of clinical applications for Illuccix in France, making it suitable for primary staging in high-risk prostate cancer patients before curative therapy.
It is applicable to those with suspected recurrent prostate cancer, indicated by rising serum prostate-specific antigen levels post-primary treatment. Illuccix also helps in identifying patients with PSMA-positive progressive metastatic castration-resistant prostate cancer who could benefit from PSMA-targeted therapies.
Telix International CEO Raphaël Ortiz said: “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.”
According to Telix, PSMA-PET imaging has been recognised as a significant advancement in managing prostate cancer. It provides clinicians with more detailed information compared to traditional imaging techniques like bone scans and CT scans.
This advanced imaging method is now considered a new standard of care following initial diagnosis and biochemical recurrence. Illuccix’s broad approval in France is supported by substantial clinical evidence, including data from the VISION trial, which represents the largest dataset based on gallium-68 PSMA.
The approval aims to address access challenges by enabling hospitals and clinics to conduct PSMA-PET scans on-site, thus providing healthcare professionals with a more efficient and readily available solution.
With its wide-ranging indications and ready-to-use formulation, Illuccix is designed to assist healthcare providers in delivering reliable imaging services. This development comes as the demand for PSMA-PET imaging increases across Europe, highlighting the need for solutions that are compatible with existing hospital workflows.
Telix has partnered with IRE ELiT, a radiopharmaceutical subsidiary of the IRE Group, to promote Illuccix to healthcare professionals in France.
The product had already been approved by regulatory bodies in the US, Australia, Canada, the UK, and various other European Economic Area member states.
Illuccix continues to be under national approval review across the European Economic Area, following a positive opinion from the decentralized procedure conducted by BfArM.
Previously, Telix announced that the Dutch Medicines Evaluation Board had granted marketing authorisation for Illuccix, enabling healthcare providers in the Netherlands to offer PSMA-PET imaging using this clinically validated gallium-based radiopharmaceutical.
