Melbourne, Australia-based pharmaceutical company Telix has received U.S. Food and Drug Administration (FDA) approval for Pixclara (F-18 floretyrosine), making it the first FDA-approved PET imaging agent for glioma.
Pixclara is indicated 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, the company noted in a September 14 statement. The drug works by targeting L-type amino acid transporters 1 and 2 (LAT1 and LAT2), which are upregulated in tumor tissue.
F-18 floretyrosine (FET) PET imaging has been recommended in international clinical practice guidelines for gliomas, including National Comprehensive Cancer Network guidelines, but no FDA-approved product has been available in the U.S. Gliomas account for approximately 30% of all brain and central nervous system tumors and 80% of malignant brain tumors, with roughly 24,000 new cases diagnosed each year in the U.S., according to the company.
The clearance comes after Telix’s resubmitted its original New Drug Application in March, with the FDA requiring agency required additional confirmatory clinical evidence. The FDA first granted fast-track designation to the radiotracer in April, 2024.
The FDA based its safety evaluation on 382 patients with gliomas, including 371 adults who received a mean activity of 204 MBq and 11 pediatric patients who received a mean of 155 MBq. The drug demonstrated a favorable safety profile: headache was the only adverse reaction occurring in 0.5% or more of patients, while nausea, injection site reaction, fatigue, and malaise each occurred in fewer than 0.5%.
"Having an FDA-approved FET-PET product with high diagnostic accuracy will make a significant, positive difference to the management of patients with gliomas," said Patrick Wen, MD, of Mass General Brigham Cancer Institute. "This is a very positive step forward for brain cancer imaging and treatment planning."
Pixclara is currently also under investigation in a phase III registrational study for potential indication expansion for the diagnosis of brain metastases, the company noted.
