Australian biopharmaceutical company Telix Pharmaceuticals Limited (ASX: TLX) (Nasdaq: TLX) announced on Thursday that it has received a positive decision on the Marketing Authorisation Application (MAA) for its prostate cancer PET imaging agent Illuccix (kit for the preparation of gallium-68 gozetotide injection) that was submitted in Europe through decentralised procedure (DCP).

This milestone follows the Final Assessment Report from the German Competent Authority BfArM as Reference Member State (RMS).

Through the DCP, the RMS and all 18 European Economic Area (EEA) Concerned Member States (CMS) agree that the product will receive marketing authorisation. The DCP regulatory process will now transition into an administrative national phase to apply authorisations to facilitate commercial launch in each country.

Telix said that 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).