- Pixclara® is the first FDA-approved FET-PET imaging drug for glioma (brain cancer).
- Approval addresses a significant unmet need, helping physicians to differentiate recurrent or progressive glioma from treatment-related change in adults and pediatric patients.
- FET-PET imaging is recommended in international clinical practice guidelines, including NCCN Guidelines®.
- Pixclara expands Telix’s industry-leading Precision Medicine business and reinforces the Company’s leadership in diagnostics and targeted radiopharmaceutical therapies (together, "theranostics").
MELBOURNE, Australia and INDIANAPOLIS, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ:TLX, "Telix") today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pixclara® (floretyrosine F 18 or 18F-FET), an amino acid positron emission tomography (PET) drug for imaging gliomas (brain cancer).
Pixclara is a radioactive diagnostic drug indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.
PET imaging with floretyrosine F 18 (FET-PET) is recommended in international clinical practice guidelines for the imaging of gliomas, including NCCN Guidelines®1, but until now there has not been an FDA-approved product available in the U.S.
Gliomas are the most common form of central nervous system (CNS) cancer, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors2. In the U.S., approximately 24,000 new glioma cases are diagnosed each year3, representing a significant unmet addressable need.