First U.S. Patients Receive Telix’s Pixclara for Glioma PET Imaging

Telix Pharmaceuticals has announced that the first U.S. patients have been dosed with Pixclara (floretyrosine F 18, or 18F-FET), marking the commercial launch of the recently FDA-approved PET imaging agent for glioma.

The first doses were administered at the Indiana University Health Neuroscience Center in Indianapolis and University Hospitals Cleveland Medical Center in Ohio. PharmaLogic Holdings Corp., Telix’s U.S. manufacturing and pharmacy distribution partner, is supplying finished doses to the U.S. market.

Pixclara is the only FDA-approved radiopharmaceutical imaging drug for glioma. The agent is indicated for PET imaging to help 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.

“Distinguishing recurrent or progressive gliomas from treatment-related change is one of the most difficult and consequential challenges in brain cancer,” said Na Tosha N. Gatson, MD, PhD, FAAN, director of the Center for Neuro-Oncology at IU Health-Indiana University School of Medicine. She said access to FDA-approved FET-PET imaging with Pixclara could support “more timely and accurate decisions” and more confident treatment planning.

FET-PET imaging is recommended in international clinical practice guidelines, including National Comprehensive Cancer Network guidelines. Approximately 24,000 new glioma cases are diagnosed annually in the U.S. Gliomas account for about 30% of all brain and central nervous system tumors and 80% of malignant brain tumors.

“The first commercial dose of Pixclara is an important milestone for a patient community that has seen limited advances in diagnosis and treatment for many years,” said Kevin Richardson, CEO of Telix Precision Medicine.

Pixclara targets L-type amino acid transporters LAT1 and LAT2 and is labeled with fluorine-18 for PET detection. Telix is also evaluating the agent in a Phase 3 registrational study for a potential expanded indication in the diagnosis of brain metastases.

Safety was evaluated in 382 patients with gliomas, including 371 adults and 11 pediatric patients. Headache was reported in 0.5% of patients; nausea, injection-site reactions, fatigue, and malaise each occurred in fewer than 0.5%.