Telix Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pixclara (floretyrosine F 18 or 18F-FET), an amino acid Positron Emission Tomography (PET) drug for imaging gliomas (brain cancer).

Pixclara is a radioactive diagnostic drug indicated for use with PET 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.

PET imaging with floretyrosine F 18 (FET-PET) is recommended in international clinical practice guidelines for the imaging of gliomas, including NCCN Guidelines, but until now there has not been an FDA-approved product available in the US.

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, "FDA approval of Pixclara will enable broad access in the US to FET-PET imaging, which is already recognised in international clinical practice guidelines. As the first FDA-approved PET imaging drug for glioma, Pixclara will provide physicians in the US with more certainty in their diagnoses and greater confidence in their treatment planning for patients."

Gliomas are the most common form of Central Nervous System (CNS) cancer, accounting for approximately 30 percent of all brain and CNS tumors and 80 percent of all malignant brain tumors.

Kelly Sitkin, President and CEO, American Brain Tumor Association, said, "The approval of Pixclara will advance glioma care by enabling more precise monitoring, complementing the role of MRI. We welcome the FDA's decision, which provides a pathway to access this technology in the US and helps address a critical unmet need in brain cancer diagnostics."

In the US, approximately 24,000 new glioma cases are diagnosed each year, representing a significant unmet addressable need.

Patrick Wen, MD, E Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology, Mass General Brigham Cancer Institute, said, "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."