{"entity":{"id":"f-18-fet","kind":"drug","name":"Floretyrosine F-18 (FET)","aka":["18F-FET","O-(2-[18F]fluoroethyl)-L-tyrosine","Pixclara","TLX101-Px"],"tldr":"A brain-tumour PET tracer that shows where active tumour tissue is by how much it grabs a labelled amino acid, which helps tell a true regrowing tumour apart from scan changes caused by past treatment. Approved by the FDA in September 2026, the first scan of its kind cleared for this use in the US.","summary":"Pixclara (floretyrosine F 18, 18F-FET) was approved by FDA on 11 September 2026 (the PDUFA goal date), after an initial complete response letter in April 2025 requesting additional confirmatory clinical evidence and a resubmission by Telix in March 2026. It is indicated for use with PET to differentiate recurrent or progressive glioma from treatment-related change, alongside other diagnostic evaluations, in adults and children from 1 month of age -- making it the first FDA-approved radiopharmaceutical imaging drug for glioma in the US. Safety was assessed in 382 glioma patients; the only adverse reaction at or above 0.5% incidence was headache, with nausea, injection-site reaction, fatigue and malaise each occurring in under 0.5%.\n\nFET-PET has been used in Europe and recommended by joint EANM/EANO/RANO/SNMMI guidelines for glioma imaging for over a decade, well ahead of US approval: recommended adult activity is 185-200 MBq, with a tumour-to-brain SUV ratio threshold of roughly 1.6-1.8 used to define biological tumour volume, and a maximum tumour-to-brain ratio of at least 2.5 associated with a 98% positive predictive value for neoplasm in newly diagnosed lesions. The Pixclara US label sets the adult dose at 185-259 MBq (5-7 mCi) and a paediatric weight-based dose from 1 month of age. The agent remains in a phase 3 registrational study for a possible brain-metastases indication, which is not yet part of the approved US label.","status":"approved","asOf":"2026-09-27","links":[{"label":"Drugs@FDA: NDA 218592, Pixclara (floretyrosine F 18)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218592"},{"label":"Pixclara (floretyrosine F 18) US Prescribing Information, Telix Pharmaceuticals","url":"https://telixpharma.com/wp-content/uploads/2026/09/USPI_PIXCLARA_Sep2026.pdf"},{"label":"Telix press release: FDA approves Pixclara, 14 September 2026","url":"https://telixpharma.com/news-views/fda-approves-telixs-brain-cancer-imaging-drug-pixclara/"},{"label":"Joint EANM/EANO/RANO/SNMMI practice guidelines for PET imaging of gliomas with radiolabelled amino acids and FDG (2018)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC6351513/"}],"tags":["amino acid PET","glioma","newly approved"],"related":["f-18-fdopa","f-18"],"indications":["glioblastoma"],"sections":[],"technologies":["pet","pet-ct"],"targets":[],"drugs":[],"companies":["telix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Pixclara","modality":"PET tracer","mechanism":"An amino-acid analogue taken up by the L-type amino-acid transporters (LAT1/LAT2) that are upregulated on glioma cells, without being metabolically incorporated into protein. Because uptake tracks amino-acid transport rather than glucose metabolism, it gives much better contrast than FDG in the brain, where normal grey matter is a high glucose consumer but a low amino-acid transporter.","approvals":[{"region":"US","year":2026,"indication":"Use with PET to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and paediatric patients 1 month of age and older"}],"mechanismSteps":[],"dosing":{"route":"Intravenous bolus injection","schedule":"Adults: 185-259 MBq (5-7 mCi); paediatric patients 1 month and older: 3 MBq/kg (0.081 mCi/kg), minimum 14 MBq, maximum 259 MBq","source":"https://telixpharma.com/wp-content/uploads/2026/09/USPI_PIXCLARA_Sep2026.pdf"},"toxicity":[{"event":"Headache","anyGradePct":0.5,"source":"https://telixpharma.com/wp-content/uploads/2026/09/USPI_PIXCLARA_Sep2026.pdf"}],"access":[],"regulatoryEvents":[{"date":"2026-09-11","type":"approval","region":"US","note":"Pixclara, NDA 218592 (Telix Pharmaceuticals US), original approval; FDA classification Type 1 new molecular entity","source":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218592"}]},"route":"/drugs/f-18-fet/","neighbours":{"drug":[{"id":"f-18-fdopa","kind":"drug","name":"Fluorodopa F-18","route":"/drugs/f-18-fdopa/"}],"isotope":[{"id":"f-18","kind":"isotope","name":"Fluorine-18","route":"/isotopes/f-18/"}],"indication":[{"id":"glioblastoma","kind":"indication","name":"Glioma & glioblastoma","route":"/indications/glioblastoma/"}],"technology":[{"id":"pet","kind":"technology","name":"PET (positron emission tomography)","route":"/technologies/pet/"},{"id":"pet-ct","kind":"technology","name":"PET/CT","route":"/technologies/pet-ct/"}],"company":[{"id":"telix","kind":"company","name":"Telix Pharmaceuticals","route":"/companies/telix/"}]}}