On September 14, 2026 Telix reported 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).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 tumors[2]. In the U.S., approximately 24,000 new glioma cases are diagnosed each year[3], representing a significant unmet addressable need.
Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, "FDA approval of Pixclara will enable broad access in the U.S. to FET-PET imaging, which is already recognized in international clinical practice guidelines. As the first FDA-approved PET imaging drug for glioma, Pixclara will provide physicians in the U.S. with more certainty in their diagnoses and greater confidence in their treatment planning for patients."
Kelly Sitkin, President and CEO, American Brain Tumor Association, said, "The approval of Pixclara will advance glioma care by enabling more precise monitoring, complementing the role of MRI. We welcome the FDA’s decision, which provides a pathway to access this technology in the U.S. and helps address a critical unmet need in brain cancer diagnostics."
Patrick Wen, MD, E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, said, "Having an FDA-approved FET-PET product with high diagnostic accuracy will make a significant, positive difference to the management of patients with gliomas. This is a very positive step forward for brain cancer imaging and treatment planning."
About Pixclara (floretyrosine F 18)
Pixclara is an intravenous positron emission tomography (PET) imaging drug for the differentiation of 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. It comprises a small molecule targeting compound labeled with a diagnostic radioisotope, fluorine-18. After administration into the bloodstream, Pixclara targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). Once bound, energy emissions from the radioisotope can be detected by a PET scanner. Pixclara (TLX101-Px) is also the subject of a Phase 3 registrational study for potential indication expansion for the diagnosis of brain metastases[4].
Pixclara is the only FDA-approved radiopharmaceutical imaging drug for glioma (brain cancer).
INDICATIONS AND USAGE
PIXCLARA is 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.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Risk for Misinterpretation
Image misinterpretation may occur with PIXCLARA PET. A negative image does not rule out the presence of recurrent or progressive glioma and a positive image does not confirm the presence of recurrent or progressive glioma. Equivocal findings may occur with PIXCLARA PET, including low-level or atypical uptake patterns, which may result in false positive or false negative interpretations.
Interpret PIXCLARA PET findings with caution and correlate results with available clinical evaluations, such as histopathology, cross-sectional imaging, and/or clinical history to support appropriate clinical decision-making.
Radiation Risks
PIXCLARA contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.
ADVERSE REACTIONS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of PIXCLARA was evaluated in 382 patients with gliomas. Among these 382 patients, 371 adult patients received at least one intravenous dose of PIXCLARA at a mean activity of 204 ± 18 MBq (5.5 ± 0.47 mCi). The remaining 11 pediatric patients received at least one intravenous dose of PIXCLARA at a mean activity of 155 ± 53.5 MBq (4.2 ± 1.4 mCi).
The mean age of the patients was 57 years (range: 5 years to 86 years). Sex was 59% male, 37% female, and 3% unreported. Distribution by race was 26% White, 6% Asian, <1% Black or African American, and 67% other or unreported. Distribution by ethnicity was 3% Hispanic/Latino, 96% non-Hispanic/Latino, and <1% unknown or unreported.
Adverse reactions that occurred in ≥0.5% of patients receiving PIXCLARA were headache (0.5%).
Adverse reactions that occurred in <0.5% of patients were nausea, injection site reaction, fatigue, and malaise.
Adverse Reactions in Pediatric Patients
Overall, the safety profile observed in pediatric patients from the clinical study was consistent with the safety profile in adult patients.
(Press release, Telix Pharmaceuticals, SEP 14, 2026, View Source [SID1234670776])