• Pixclara® is the first FDA-approved FET-PET imaging drug for glioma (brain cancer).
• Approval addresses a significant unmet need, helping physicians to differentiate recurrent or progressive glioma from treatment-related change in adults and pediatric patients.
• FET-PET imaging is recommended in international clinical practice guidelines, including NCCN Guidelines®.
• Pixclara expands Telix's industry-leading Precision Medicine business and reinforces the Company's leadership in diagnostics and targeted radiopharmaceutical therapies (together, "theranostics").

Telix Pharmaceuticals Limited announces that the United States (U.S.) 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).

PET imaging with floretyrosine F 18 (FET-PET) is recommended in international clinical practice guidelines for the imaging of gliomas, including NCCN Guidelines®^[1], but until now there has not been an FDA-approved product available in the U.S.

Gliomas are the most common form of central nervous system (CNS) cancer, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors^[2]. In the U.S., approximately 24,000 new glioma cases are diagnosed each year^[3], representing a significant unmet addressable need.

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, "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. 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, 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 U.S. and helps address a critical unmet need in brain cancer diagnostics."

Patrick Wen, MD, E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at 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."