FDA Approves Telix’s Pixclara for Glioma PET Imaging

The US Food and Drug Administration (FDA) has approved Telix Pharmaceuticals’ Pixclara (floretyrosine F 18; 18F-FET), making it the first FDA-approved FET-PET imaging drug for glioma.

Pixclara is indicated for PET imaging to differentiate recurrent or progressive glioma from treatment-related changes, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.

FET-PET imaging is recommended in international clinical practice guidelines for glioma, including the National Comprehensive Cancer Network (NCCN) Guidelines, but an FDA-approved FET-PET agent had not previously been available in the United States.

Gliomas are the most common form of central nervous system cancer, accounting for approximately 30% of all brain and CNS tumors and 80% of malignant brain tumors. Approximately 24,000 new glioma cases are diagnosed annually in the US.

“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,” said Kevin Richardson, chief executive officer of Telix Precision Medicine. “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 of the American Brain Tumor Association, said the approval could improve glioma monitoring while complementing MRI.

“The approval of Pixclara will advance glioma care by enabling more precise monitoring, complementing the role of MRI,” Sitkin said. “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, of Mass General Brigham Cancer Institute, added, “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.”

Pixclara is an intravenous PET imaging agent labeled with fluorine-18 that targets L-type amino acid transporters LAT1 and LAT2. The agent, also known as TLX101-Px, is additionally being evaluated in a Phase 3 registrational study for potential use in diagnosing brain metastases.