Telix Pharmaceuticals has announced an agreement with the US Food and Drug Administration (FDA) to resubmit its application for approval of its brain cancer imaging agent. This decision follows earlier setbacks when the FDA declined to approve Telix’s Pixclara diagnostic tool, used for identifying gliomas, a deadly form of brain cancer. Telix Pharmaceuticals is a biopharmaceutical company focused on developing diagnostic and therapeutic products using molecularly targeted radiation. The company aims to address unmet medical needs in oncology and other areas.
The FDA had previously requested additional evidence regarding the benefits of Pixclara before granting approval. In response, Telix has been working to gather the necessary data and address the FDA’s concerns. On Tuesday, Telix reported it had received detailed feedback concerning a resubmission package that will incorporate an additional efficacy study. The company believes that this study will adequately meet the FDA’s requirements for further evidence supporting the efficacy of Pixclara in diagnosing gliomas.
The planned efficacy study is designed to provide robust data demonstrating the clinical utility of Pixclara. Telix anticipates that the results will reinforce the value of the imaging agent in improving the diagnosis and management of glioma patients. According to Telix chief medical officer David Cade, the company remains focused on its goal of bringing this important imaging agent to patients in the US to support improved diagnosis and management of glioma.
Telix is proactively taking steps to address the FDA’s feedback and generate the necessary clinical evidence. The company is committed to working closely with the regulatory agency to facilitate the approval process and ultimately make Pixclara available to healthcare professionals and patients in need.
