The FDA has approved Pixclara® (floretyrosine F 18), Telix’s 18F-FET-PET imaging drug for glioma (brain cancer).
Pixclara is the only FDA-approved FET-PET imaging drug for glioma and is indicated 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.
FET-PET imaging is already recommended in international clinical practice guidelines, but until now there has not been an FDA-approved product.
Pixclara will provide physicians in the U.S. with greater certainty in brain cancer diagnosis and treatment planning, addressing an important unmet need.
Read more on our website here:
telixpharma.com/news-views/f…
SELECTED IMPORTANT SAFETY INFORMATION
● Image misinterpretation may occur with PIXCLARA PET. Equivocal findings may occur with PIXCLARA PET, including low-level or atypical uptake patterns, which may result in false positive or false negative interpretations.
● PIXCLARA involves exposure to small amounts of radioactivity; long-term cumulative radiation exposure is associated with increased cancer risk.
● 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.
● Overall, the safety profile observed in pediatric patients from the clinical study was consistent with the safety profile in adult patients.
This is not the full important safety information. The indications and full important safety information is available at
telixpharma.com/pixclara-usp…