Telix Pharmaceuticals Limited (TLPPF), a biopharmaceutical company, on Friday announced that its prostate cancer PET imaging agent, Illuccix, an allium-68 gozetotide injection, has received European marketing authorization.
This approval follows the successful completion of the decentralized procedure or DCP with the German Competent Authority BfArM acting as the Reference Member State.
Illuccix will be used for the detection of PSMA-positive lesions in prostate cancer patients across three clinical settings: primary staging, suspected recurrent disease, and progressive metastatic castration-resistant prostate cancer or mCRPC.
The approval marks a significant milestone for Telix and positions the company for a commercial launch of Illuccix in Europe.
Illuccix is already approved by the FDA in the United States and is a clinically important imaging tool recommended in international guidelines for prostate cancer management.
The company is poised to make a significant impact on the standard of care in prostate cancer with its innovative imaging solution.
Currently, TLPPF is trading at $16.65 up by 4.06%.
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