FDA Approves Telix's New Brain Tumor Imaging Agent Pixclara

The U.S. Food and Drug Administration (FDA) has approved a new brain tumor imaging agent developed by Australian pharmaceutical company Telix, the company announced on Monday.

The product, called Pixclara, is a radioactive diagnostic drug used in combination with positron emission tomography (PET) imaging. Its primary use is to help doctors distinguish between recurrent brain tumors and harmless changes caused by prior treatment.

The FDA approval comes after Telix faced an FDA rejection last year due to insufficient evidence.

Kevin Richardson, CEO of Telix Precision Medicine, said in a statement: "As the first FDA-approved PET imaging drug for glioma (a type of brain tumor), Pixclara will provide physicians in the United States with more definitive diagnoses and greater confidence in patient treatment planning."

Telix emphasized that this is the first FDA-approved PET imaging drug based on fluoroethyltyrosine F18 for the diagnosis of glioma in the United States. The approval will enable widespread use of FET-PET imaging technology in the United States, which has already been recognized in international clinical practice guidelines. Pixclara is indicated for adult and pediatric patients aged 1 month and older.

Glioma is the most common tumor of the central nervous system, accounting for approximately 30% of all brain and central nervous system tumors. There are approximately 24,000 new cases of glioma in the United States each year, and the approval is expected to address a significant unmet need.

The safety of the drug has been evaluated in nearly 400 brain tumor patients. Among them, 371 adult patients received at least one intravenous injection of Pixclara, along with 12 pediatric patients. The incidence of adverse reactions was less than 0.5%, including headache, nausea, injection site reactions, fatigue, and malaise. The U.S. FDA rejected Pixclara's application early last year, citing the need for more clinical evidence at the time.

Subsequently, the regulatory agency accepted the application in April of this year, and the imaging agent also received FDA Fast Track and Orphan Drug designations. Telix stated at the time that the company was planning for a Prescription Drug User Fee Act (PDUFA) target date of September 11.

Dr. Patrick Wen, Director of the Center for Neuro-Oncology at Dana-Farber Brigham Cancer Center in Massachusetts, said in a statement: "Having an FDA-approved FET-PET product with high diagnostic accuracy will have a significant and positive impact on the treatment of patients with glioma. This is an important step forward in brain tumor imaging and treatment planning."