Telix Submits NDA for Prostate Cancer Imaging Agent

MELBOURNE, Australia, May 28, 2024 - Telix Pharmaceuticals (ASX: TLX), a company focused on radiopharmaceuticals, has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for TLX007-CDx. This new cold kit aims to improve PSMA-PET imaging for prostate cancer, offering an extended distribution profile compared to existing gallium-68 (68Ga) PSMA-PET imaging agents.

This kit is designed to broaden production capabilities, using 68Ga from both high activity generators and cyclotrons, including ARTMS® QUANTM Irradiation System™ and GE FASTlab™ systems. Improved flexibility in production is expected to enhance the availability, distribution, and scheduling of PSMA-PET imaging, making this diagnostic tool more accessible.

Despite the commercial availability of PSMA-PET imaging agents in the U.S., many underserved populations, including African Americans and Veterans, continue to face limited access. These groups have higher prostate cancer incidence rates and often encounter late-stage diagnoses.

The new investigational imaging product by Telix aims to address these gaps in care. Leveraging Telix’s nuclear pharmacy distribution partnerships, the product aspires to reach a broader patient demographic and meet the needs of healthcare professionals. PSMA-PET imaging has revolutionized prostate cancer management in the U.S., becoming the standard of care after initial diagnosis and biochemical recurrence. However, only a small number of the 3.4 million U.S. men with prostate cancer have received a PSMA-PET scan.

Mike Crosby, Founder and CEO of Veterans Prostate Cancer Awareness (VPCa), highlighted the variability in access to these imaging services, especially in rural areas, which can lead to significant financial and logistical burdens for patients. Crosby believes that FDA approval of this new kit could significantly reduce these disparities, enabling earlier and more accurate cancer diagnoses, which would lower treatment costs and improve patient survival rates.

Telix’s Managing Director and Group CEO, Dr. Christian Behrenbruch, emphasized the importance of accessibility and clinical performance in promoting the widespread adoption of 68Ga-based PSMA-PET imaging. Behrenbruch noted that the company's commitment to improving access to healthcare is exemplified by the development of this new product. As demand for PSMA-PET imaging is expected to grow, such innovations are essential.

About Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited is a biopharmaceutical company specializing in the development and commercialization of diagnostic and therapeutic radiopharmaceuticals and related medical devices. Headquartered in Melbourne, Australia, with operations in the U.S., Europe, and Japan, Telix focuses on addressing significant unmet medical needs in oncology and rare diseases. The company is listed on the Australian Securities Exchange (ASX: TLX).

Telix’s primary imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has received approval from the U.S. FDA, the Australian Therapeutic Goods Administration (TGA), and Health Canada. Other products from Telix are still awaiting marketing authorization.

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