Telix Pharmaceuticals has achieved significant regulatory milestones with its prostate cancer imaging agent, Illuccix (kit for the preparation of gallium-68 gozetotide injection). The company announced that it has received a positive decision on the Marketing Authorization Application (MAA) for Illuccix in Europe and has also been approved by the Danish Medicines Agency.
European Approval
The European approval follows a decentralized procedure (DCP) where the German Competent Authority BfArM served as the Reference Member State (RMS). The RMS and 18 European Economic Area (EEA) Concerned Member States (CMS) agreed that Illuccix should receive marketing authorization. This regulatory process will now transition into an administrative national phase to implement authorizations to facilitate commercial launch in each country.
Kevin Richardson, CEO of Telix Precision Medicine, stated, "We are delighted by this positive outcome, setting the stage for a European commercial launch of Illuccix. This clinically important prostate cancer imaging modality is currently recommended in international clinical practice guidelines including European Association of Urology (EAU) and European Society for Medical Oncology (ESMO)."
Danish Approval
In Denmark, Illuccix, after radiolabelling with gallium-68, is indicated 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.
Raphaël Ortiz, CEO of Telix International, commented, "We are delighted that Illuccix has been approved in Denmark with this broad label demonstrative of clinical utility at multiple critical points in the prostate cancer journey. Danish physicians and their patients will now have access to Telix’s innovative gallium-based PSMA-PET imaging agent, along with the efficiencies and scheduling flexibility of generator-produced gallium."
Clinical Significance
PSMA-PET imaging represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT scan) as the standard of care after initial diagnosis and biochemical recurrence (BCR). European guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR/biochemical persistence (BCP).
About Illuccix
Telix’s lead 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), by the Australian Therapeutic Goods Administration (TGA), and by Health Canada. Illuccix will be made available in Denmark through Telix’s distribution partner for the Nordic region, WIIK Pharma ApS.
Prostate Cancer in Denmark
Prostate cancer is the most common cancer among Danish men, with a high incidence rate (5,250 new cases in 2022) and relatively poor survival compared to other Nordic countries.
