FDA Approves Pixclara, First FET-PET Agent for Glioma Imaging

The FDA has approved floretyrosine F 18 (18F-FET; Pixclara), making it the first FDA-approved amino acid PET imaging agent for glioma.¹ The drug is indicated for use with PET to differentiate recurrent or progressive glioma from treatment-related change in adults and pediatric patients 1 month of age and older, in conjunction with other diagnostic evaluations.

Gliomas account for approximately 30% of all brain and central nervous system tumors and 80% of malignant brain tumors, with approximately 24,000 new cases diagnosed annually in the US. FET-PET imaging is recommended in international clinical practice guidelines, including the NCCN Guidelines®, though no FDA-approved agent for this use existed prior to this approval.¹ Floretyrosine F 18 targets L-type amino acid transporters 1 and 2 (LAT1 and LAT2) on cell membranes.

"Having an FDA-approved FET-PET product with high diagnostic accuracy will make a significant, positive difference to the management of patients with gliomas,” said Patrick Wen, MD, the E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, in a news release.

"The approval of Pixclara will advance glioma care by enabling more precise monitoring, complementing the role of MRI,” said Kelly Sitkin, president and CEO, American Brain Tumor Association, added in the news release.

Safety Profile

The approval was supported by data from 382 patients with gliomas (371 adults and 11 pediatric patients). Adults received a mean activity of 204 ± 18 MBq, and pediatric patients received a mean activity of 155 ± 53.5 MBq.¹ The mean patient age was 57 years (range, 5-86).¹ The most common adverse reaction was headache, occurring in at least 0.5% of patients; nausea, injection site reaction, fatigue, and malaise each occurred in less than 0.5% of patients. The pediatric safety profile was consistent with that observed in adults.

The prescribing information includes warnings that image misinterpretation may occur, that negative images do not rule out recurrent glioma, and that equivocal findings—including low-level or atypical uptake patterns—may result in false-positive or false-negative interpretations. Use of the agent contributes to a patient's cumulative radiation exposure; safe handling and adequate patient hydration are advised.

About Pixclara

Floretyrosine F 18 is developed by Telix Pharmaceuticals Limited, a commercial-stage radiopharmaceutical company headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America, and the Asia-Pacific region. The company's commercial portfolio also includes gallium-68 gozetotide, marketed as Illuccix® and Gozellix®, for prostate imaging. Telix's late-stage pipeline includes TLX591-Tx, TLX101-Tx, and TLX250-Tx, each in pivotal trials.

H6: REFERENCES

1. FDA Approves Telix's Brain Cancer Imaging Drug Pixclara. News release. Telix Pharmaceuticals Limited. September 14, 2026. Accessed September 14, 2026. https://www.globenewswire.com/news-release/2026/09/14/3360898/0/en/fda-approves-telix-s-brain-cancer-imaging-drug-pixclara.html