Telix Pharmaceuticals (ASX: TLX) Wins FDA Approval for Pixclara

Telix Pharmaceuticals has secured US Food and Drug Administration approval for Pixclara, giving the Australian radiopharmaceutical company the first approved FET-PET imaging agent for glioma in the US.

Pixclara, also known as floretyrosine F 18, is approved for use with positron emission tomography to help distinguish recurrent or progressive glioma from treatment-related changes.

The indication covers adults and children aged one month and older and requires the imaging results to be interpreted alongside other diagnostic assessments.

The approval broadens Telix’s US precision-diagnostics portfolio, although the company did not disclose launch timing, pricing or expected revenue from the product.

First FDA-Approved FET-PET Agent for Glioma

Determining whether a glioma has returned or progressed can be difficult because changes caused by treatment can resemble active disease on conventional imaging.

Pixclara is designed to provide physicians with an additional diagnostic tool alongside techniques including magnetic resonance imaging.

FET-PET is already recognised in international clinical practice guidelines, including those issued by the National Comprehensive Cancer Network for central nervous system cancers. Until now, however, there had been no FDA-approved FET-PET imaging drug available in the US.

Telix said Pixclara is also the only FDA-approved radiopharmaceutical imaging agent specifically indicated for glioma.

Addressing a Significant Diagnostic Market

Gliomas are the most common form of central nervous system cancer and account for about 30% of all brain and central nervous system tumours, according to data cited by Telix.

They represent roughly 80% of malignant brain tumours.

Around 24,000 new glioma cases are diagnosed annually in the US, based on incidence data covering 2018 through 2022.

The approval therefore gives US clinicians access to an imaging technique already incorporated into international treatment guidelines across both adult and paediatric patients.

How Pixclara Works

Pixclara combines a small-molecule targeting compound with fluorine-18, a radioactive isotope widely used in PET imaging.

The drug targets L-type amino acid transporters 1 and 2, which are expressed on tumour cells. After intravenous administration, emissions from fluorine-18 can be detected by a PET scanner to help identify areas of suspected disease.

The resulting images are then assessed alongside other clinical and diagnostic information to determine whether a glioma is recurring or progressing.

Telix is separately studying the product, under the development designation TLX101-Px, for the potential diagnosis of brain metastases.

A Phase 3 registrational study is planned for that proposed indication, with the FDA having cleared the associated investigational new drug application and notified Telix that the trial may proceed.

US Diagnostics Portfolio Expands

Pixclara joins Telix’s FDA-approved prostate cancer imaging products Illuccix and Gozellix within its precision-diagnostics portfolio.

Illuccix is commercially available across 22 countries, including the US, while Gozellix has also received FDA approval for prostate imaging.

Telix is separately developing radiopharmaceutical therapies targeting prostate cancer, recurrent glioblastoma and kidney cancer. Those therapeutic candidates remain investigational and have not received marketing approval in any jurisdiction.