FDA Approves Pixclara® for Glioma Imaging

The U.S. Food and Drug Administration (FDA) has approved Pixclara® (floretyrosine F 18 or 18F-FET), an innovative positron emission tomography (PET) drug developed by Telix Pharmaceuticals for imaging gliomas, a form of brain cancer. This approval addresses an important unmet need by allowing healthcare professionals to distinguish between recurrent or progressive glioma and treatment-related changes in both adults and pediatric patients aged 1 month and older.

FET-PET imaging has been included in international clinical practice guidelines such as the National Comprehensive Cancer Network (NCCN) Guidelines®, but no FDA-approved product has been available in the U.S. until now. Gliomas are the most prevalent type of central nervous system cancer, constituting around 30% of all brain and CNS tumors and 80% of malignant brain tumors. Approximately 24,000 new cases of glioma are diagnosed annually in the United States, highlighting the necessity for improvements in diagnostic capability.

Kevin Richardson, CEO of Telix Precision Medicine, commented on the approval, stating that it will "enable broad access in the U.S. to FET-PET imaging, which is already recognized in international clinical practice guidelines." He emphasized that Pixclara's introduction would enhance diagnostic certainty for physicians and improve treatment planning for patients.

Kelly Sitkin, President and CEO of the American Brain Tumor Association, welcomed the FDA’s decision, noting, "The approval of Pixclara will advance glioma care by enabling more precise monitoring, complementing the role of MRI."

Dr. Patrick Wen, an expert in neuro-oncology at Mass General Brigham Cancer Institute, remarked that the availability of an FDA-approved FET-PET product with high diagnostic accuracy represents a significant advancement in the management of glioma patients, positively impacting imaging and treatment strategies.

Pixclara (TLX101-Px) functions as an intravenous PET imaging drug that differentiates recurrent or progressive glioma from treatment-related changes by targeting the L-type amino acid transporters 1 and 2 (LAT1 and LAT2) after being administered into the bloodstream. It emits energy detectable by a PET scanner. The drug is currently undergoing a Phase 3 registrational study for potential expansion to indicate brain metastases.

As with any medication, Pixclara comes with risks, including the potential for image misinterpretation, which could lead to false positives or negatives. Precautions are advised when interpreting PET findings, and clinical evaluations should always accompany results.

In clinical trials involving 382 patients with gliomas, the safety profile of Pixclara was established, with minimal adverse reactions noted. The most common adverse effect reported in 0.5% of patients was a headache, while others included nausea, injection site reactions, fatigue, and malaise.

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