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Telix Pharmaceuticals Submits Biologics License Application (BLA) for Zircaix™ (TLX250-CDx) for Imaging in Kidney Cancer

Tuesday, December 19, 2023

Telix Pharmaceuticals Limited (ASX: TLX) has officially submitted its Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for TLX250-CDx, an investigational positron emission tomography (PET) imaging agent designed for clear cell renal cell carcinoma (ccRCC). The Breakthrough Therapy designation has granted TLX250-CDx a rolling review process, facilitating a progressive submission and review of necessary modules in a pre-agreed timetable. Simultaneously, Telix has requested Priority Review, potentially expediting the overall review time.

Dr. Christian Behrenbruch, Managing Director and Telix Group CEO, expressed the significance of this milestone, anticipating potential commercial availability for U.S. patients in 2024, contingent upon regulatory approval. James Stonecypher, Chief Development Officer at Telix, highlighted the groundbreaking nature of TLX250-CDx, as it could become the first commercially available targeted radiopharmaceutical imaging agent for kidney cancer patients in the U.S. The collaborative efforts with the FDA under the Breakthrough Therapy designation were commended for their value in advancing the novel imaging agent to market.

According to Associate Professor Brian Shuch, MD, Director of the Kidney Cancer Program at UCLA Institute of Urologic Oncology, the ZIRCON study demonstrated the superior sensitivity and specificity of TLX250-CDx, addressing a critical unmet need for diagnosing ccRCC, the most aggressive and prevalent form of kidney cancer. If approved, TLX250-CDx would be the first agent targeting carbonic anhydrase IX, a highly relevant marker in kidney cancer.

The BLA submission is grounded in the positive results from Telix's global Phase III ZIRCON study ( ID: NCT03849118), which concluded in November 2022, meeting all co-primary and secondary endpoints. To provide access outside of clinical trials for patients lacking satisfactory alternatives, Telix has initiated an expanded access program in the U.S. and a named patient program in Europe for TLX250-CDx.



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