Telix Pharmaceuticals Submits MAA for TLX101-Px in Europe

Telix Pharmaceuticals announces that it has submitted a marketing authorization application, or MAA, in Europe for TLX101-Px, its glioma imaging candidate. Telix has been preparing the European and U.S. regulatory packages for TLX101-Px concurrently, bringing forward the European submission to meet an agreed filing date while aligning with aspects of the FDA package to support the additional application. The submission covers major European markets1. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines2. Submission of the U.S. New Drug Application, or NDA, will follow. In Europe, positron emission tomography, or PET, imaging of glioma with 18F-FET is currently performed under physician-supervised use through hospital-based production at a limited number of sites. Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications. In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year6, with gliomas accounting for approximately 30% of these, and up to 80% of all malignant brain tumors. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumors of the central nervous system, particularly in the post-treatment setting.