Telix Submits TLX250-CDx BLA for Kidney Cancer Imaging

Telix Pharmaceuticals (ASX: TLX), based in Melbourne, Australia, has successfully completed its Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for its investigational PET imaging agent, TLX250-CDx (Zircaix®). This agent is designed for the characterisation of renal masses as clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.

Key Milestone Achieved

The BLA submission, initiated in December 2023, follows Telix’s global Phase III ZIRCON study. This study evaluated TLX250-CDx in patients with ccRCC and met all co-primary and secondary endpoints. The trial demonstrated a sensitivity of 86%, specificity of 87%, and a positive predictive value (PPV) of 93% for detecting ccRCC, even in small and challenging-to-detect lesions.

Priority Review Request

Telix has requested a Priority Review under the Breakthrough Therapy designation criteria, which could expedite the review process. If approved, TLX250-CDx would be the first targeted radiopharmaceutical imaging agent available in the U.S. specifically for kidney cancer, further enhancing Telix’s urology imaging portfolio.

Significance of TLX250-CDx

James Stonecypher, Chief Development Officer at Telix, highlighted the importance of this milestone. He emphasized that TLX250-CDx, as a non-invasive diagnostic tool, would be a valuable addition to Telix’s product lineup, complementing their existing product, Illuccix®. TLX250-CDx aims to serve the same clinical stakeholders, including urologists and urologic oncologists, leveraging Telix’s established commercial and distribution infrastructure.

Expanded Access Programs

In addition to the U.S., Telix is committed to providing access to TLX250-CDx through expanded access programs (EAP) and named patient programs (NPPs) in Europe and a special access scheme (SAS) in Australia. These initiatives are designed to ensure that patients without comparable or satisfactory treatment options can still benefit from TLX250-CDx outside of clinical trials.

About TLX250-CDx (Zircaix®)

TLX250-CDx is a PET diagnostic imaging agent developed to non-invasively characterise renal masses as either ccRCC or non-ccRCC. The pivotal Phase III ZIRCON trial, which included 300 participants, demonstrated high accuracy and consistency in detecting the clear cell phenotype of renal cancer. The study’s results showed an 86% sensitivity, 87% specificity, and a 93% PPV, supporting the reliability of TLX250-CDx in diagnosing ccRCC.

About Telix Pharmaceuticals Limited

Telix Pharmaceuticals Ltd. is a biopharmaceutical company focused on developing and commercialising diagnostic and therapeutic radiopharmaceuticals. Headquartered in Melbourne, Australia, Telix operates internationally, including in the U.S., Europe, and Japan. The company is dedicated to addressing unmet medical needs in oncology and rare diseases.

Telix's leading imaging product, Illuccix® (68Ga PSMA-11), has already received approvals from the U.S. FDA, the Australian Therapeutic Goods Administration (TGA), and Health Canada. TLX250-CDx, if approved, would expand Telix's portfolio and enhance its impact in the field of radiopharmaceuticals.

Conclusion

Telix Pharmaceuticals' submission of the BLA for TLX250-CDx marks a significant advancement in non-invasive kidney cancer diagnostics. The company’s dedication to improving patient access through expanded access programs underscores its commitment to addressing critical healthcare needs. As Telix awaits the FDA’s decision, the potential approval of TLX250-CDx could represent a major step forward in kidney cancer imaging and diagnosis.

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