Telix Pharmaceuticals (TLX) said Thursday it received a positive decision on its marketing authorization application for Illuccix, its prostate cancer positron emission tomography imaging agent, in Europe.
The application was submitted via a decentralized procedure, with the German Federal Institute for Drugs and Medical Devices acting as the reference member state. The RMS and all 18 European Economic Area Concerned Member States have agreed that Illuccix should receive marketing authorization.
This decision sets the stage for the administrative national phase, where authorizations will be finalized to facilitate the commercial launch of Illuccix across the region.
Once launched, Illuccix will enable the detection of prostate-specific membrane antigen-positive lesions with PET imaging in adults with prostate cancer, according to the company.
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