#Australia #Melbourne #Prostate Cancer #Telix Pharmaceuticals #Illuccix

Telix Pharmaceuticals' Illuccix® Achieves European Approval

In a landmark development for prostate cancer diagnostics, Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX) has secured positive approval for its imaging agent, Illuccix®, within European markets. This approval follows the successful Marketing Authorization Application (MAA) submission through a decentralized procedure (DCP), allowing for a streamlined regulatory process across the European Economic Area (EEA).

On January 16, 2025, the company announced the landmark decision after obtaining a favorable Final Assessment Report from the German Competent Authority (BfArM), which acted as the Reference Member State (RMS). With the DCP process now complete, Telix is set to transition into the national phase of approvals necessary for commercial launch throughout various European nations. Kevin Richardson, the CEO of Telix Precision Medicine, expressed enthusiasm about the decision, emphasizing its importance in enhancing clinical practices for prostate cancer diagnostics.

Illuccix®, featuring gallium-68 gozetotide, is recognized for its ability to detect prostate-specific membrane antigen (PSMA) positive lesions through positron emission tomography (PET) imaging. This advancement is aligned with international clinical practice guidelines supported by leading organizations such as the European Association of Urology (EAU) and the European Society for Medical Oncology (ESMO).

The significance of PSMA-PET imaging cannot be understated, marking a shift in prostate cancer evaluation standards. This innovative approach surpasses traditional imaging techniques like bone scans and CT scans, establishing itself as the preferred method for accurately staging primary prostate cancer and assessing biochemical recurrence. European guidelines have underlined PSMA-PET's superior efficacy in evaluating primary disease staging and biochemical persistence, facilitating better treatment outcomes for patients.

Illuccix® is Telix's flagship imaging product and is already approved by the U.S. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), and Health Canada. Upon its European launch, Illuccix® will be used in several clinical scenarios, including:

• - Primary Staging: For high-risk prostate cancer patients prior to curative therapy.
• - Recurrent Evaluation: For patients showing rising prostate-specific antigen (PSA) levels post-primary therapy.
• - Metastatic Identification: For patients with progressive metastatic castration-resistant prostate cancer, for whom PSMA-targeted therapies are indicated.

Founded with the mission to address critical unmet medical needs, Telix Pharmaceuticals focuses on developing radiopharmaceuticals and associated medical technologies. Headquartered in Melbourne, Australia, and with a global presence in key regions including the United States, Canada, and Europe, Telix continues to expand its portfolio aimed at oncology and rare diseases. Investors and stakeholders can find more information about Telix, including the latest updates and stock performance, through their official website and various social media channels.

The recent approval of Illuccix® is a noteworthy triumph not just for Telix, but also for the field of oncology as it opens new avenues in effectively diagnosing and managing prostate cancer, ultimately leading to improved patient outcomes and quality of life.

For more updates on Telix and its innovative solutions, follow them on platforms like LinkedIn and X, or visit their website: www.telixpharma.com.