Telix Pharmaceuticals has secured landmark approval from the United States Food and Drug Administration for Pixclara, making it the first FDA-sanctioned imaging agent for glioma, the most common form of brain cancer.
Pixclara, known scientifically as floretyrosine F 18 or 18F FET, is an amino acid positron emission tomography drug designed to help physicians distinguish between a glioma that has returned or is progressing and changes in the brain caused by treatment itself.
Gliomas account for roughly 30 per cent of all brain and central nervous system tumours and 80 per cent of malignant brain tumours, according to figures Telix cited from a 2012 study in Cancer Genetics.
In the United States alone, close to 24,000 new cases are diagnosed every year, based on the most recent CBTRUS statistical report covering 2018 to 2022. FET PET imaging has already been endorsed in international clinical practice guidelines, including those from the National Comprehensive Cancer Network, yet no FDA-approved product has been available to deliver it in the American market.
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 recognised 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.”
Pixclara targets membrane transport proteins called L-type amino acid transporters 1 and 2, or LAT1 and LAT2. Once the drug is injected and binds to these transporters, the radioactive fluorine-18 label it carries emits signals that a PET scanner can detect, allowing clinicians to visualise tumour activity. Telix is not stopping at glioma. The same compound, referred to in its pipeline as TLX101 Px, is now the subject of a Phase 3 registrational study exploring its use in detecting brain metastases, an indication the company hopes will expand Pixclara's reach well beyond its initial approval.
Pixclara joins two other FDA-approved diagnostics in the Telix portfolio, Illuccix for prostate imaging, which is commercially available in 22 countries, and Gozellix, also used in prostate imaging. Behind those sit three investigational therapies in pivotal-stage trials, covering prostate cancer, recurrent glioblastoma and kidney cancer, none of which have yet received marketing authorisation anywhere in the world.
