FDA Rejects New Kidney Cancer Imaging Application From Telix Pharmaceuticals

The U.S. Food and Drug Administration has rejected the initial application from Australia-based Telix Pharmaceuticals Ltd. for a new PET imaging agent designed for kidney cancer. The announcement was made on July 31 regarding the TLX250-CDx investigational agent, also known as Zircaix, intended for treating clear cell renal cell carcinoma.

Telix stated that the FDA's concerns were centered around the need to demonstrate adequate sterility assurance during the drug's dispensing in the radiopharmacy production setting. However, the company pointed out that all batches submitted during the application process met the FDA’s sterility standards. Once approved, Telix is confident that this will be the first targeted imaging agent for noninvasive detection of renal cancer.

Christian Behrenbruch, PhD, MBA, Managing Director annd Group CEO at Telix, said “We have been working closely with the FDA through the [Biologics License Application] rolling review due to the novel nature of this product candidate and value the FDA’s constructive feedback at this early stage in the process. We expect to be able to satisfy its requirements within a minimal time frame and continue to see a clear path to product commercialization in 2025.”

Telix highlighted that the FDA has not pointed out any data deficiencies regarding the clinical safety or efficacy of TLX250-CDx. The company anticipates finishing any necessary remedial actions within 90 days and will resubmit the application afterward. Telix also intends to hold a meeting with the agency in the coming month to discuss and finalize the “necessary submission amendments.” The delay is not expected to affect the company’s revenue projections or research and development expenses for 2024. Telix reaffirmed its earlier revenue guidance, estimating between $490 million and $510 million (USD) for this year.