Melbourne-based Telix Pharmaceuticals has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its Biologics License Application for TLX250-CDx (Zircaix). This investigational PET imaging agent is designed for diagnosing clear cell renal cell carcinoma. Telix Pharmaceuticals is a biopharmaceutical company focused on developing diagnostic and therapeutic products using molecularly targeted radiation. The company is dedicated to improving outcomes for patients with cancer and rare diseases.
The FDA’s CRL identified deficiencies within the Chemistry, Manufacturing, and Controls (CMC) package. Specifically, the FDA is requesting additional data to ensure comparability between the drug product used in clinical trials and that produced at commercial scale. These concerns stem partly from notices of deficiency (Form 483) issued to two of Telix’s third-party manufacturing partners, which also require remediation.
Telix has stated that these issues are addressable and the company intends to begin remediation efforts immediately. Management plans to request a Type A meeting with the FDA to align on a clear timeline for resubmission of the application. Despite this setback, TLX250-CDx maintains its Breakthrough Therapy designation and Priority Review status with the FDA, highlighting the unmet medical need it addresses.
Dr. Christian Behrenbruch, Chief Executive Officer of Telix, commented that the company considers the outstanding matters resolvable. He anticipates that Telix will be able to address the FDA’s requests within a reasonable timeframe. The company will provide further updates as it progresses with the remediation and resubmission process.
