Telix Pharmaceuticals (ASX: TLX) has received a positive decision on the Marketing Authorisation Application (MAA) for its prostate cancer PET imaging agent Illuccix which was submitted in Europe via a decentralised procedure (DCP).
This significant milestone follows the issuance of the Final Assessment Report from the German Competent Authority as Reference Member State (RMS). Through the DCP, the RMS and all 18 European Economic Area (EEA) Concerned Member States (CMS) agree that Illuccix should receive marketing authorisation. The DCP regulatory process will now transition into an administrative national phase to implement authorisations to facilitate commercial launch in each country.
“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)," CEO Telix Precision Medicine. Kevin Richardson, said.
PSMA-PET imaging represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT6 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).
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 US Food and Drug Administration (FDA), by the Australian Therapeutic Goods Administration (TGA), and by Health Canada