The US Food and Drug Administration approved floretyrosine F 18 (Pixclara) for positron emission tomography imaging to differentiate recurrent or progressive glioma from treatment-related changes in adult and pediatric patients aged 1 month or older, according to a Telix Pharmaceuticals press release.
According to Telix, floretyrosine F 18 is the first FDA-approved FET-PET imaging drug for glioma.
Positron emission tomography (PET) imaging with floretyrosine F 18, also known as FET-PET, is recommended in international clinical practice guidelines for glioma imaging, including the National Comprehensive Cancer Network guidelines. Approximately 24,000 new cases of glioma are diagnosed annually in the US, according to the release.
Floretyrosine F 18 is administered intravenously and targets membrane transport proteins known as L-type amino acid transporters 1 and 2. Floretyrosine F 18 incorporates the radioisotope fluorine-18, allowing PET detection of emitted energy following administration.
“FDA approval of Pixclara will enable broad access in the US to FET-PET imaging, which is already recognized in international clinical practice guidelines,” said Kevin Richardson, chief executive officer of Telix Precision Medicine.
The safety of floretyrosine F 18 was evaluated in 382 patients with gliomas, including 371 adult and 11 pediatric patients. Headache occurred in 0.5% of patients. Nausea, injection-site reaction, fatigue, and malaise each occurred in fewer than 0.5%. Telix reported that the overall pediatric safety profile was consistent with that observed in adults.
The prescribing information warns that image misinterpretation may occur. PET results alone cannot exclude or establish recurrent or progressive glioma. Low-level or atypical uptake can produce equivocal results and potentially lead to false-positive or false-negative interpretations. Interpretation should incorporate other available information, including histopathology, cross-sectional imaging, and clinical history.
Use of floretyrosine F 18 adds to cumulative radiation exposure, which is associated with an increased risk of cancer.
Source: Telix
