{"entity":{"id":"floretyrosine-f18","kind":"drug","name":"Floretyrosine F 18","aka":["floretyrosine F 18","floretyrosine F18","floretyrosine","Pixclara"],"tldr":"Pixclara is a tracer for a PET scan of the brain. After treatment for a glioma, it helps doctors tell whether a change seen on a scan is the tumour growing back or damage caused by the treatment, alongside the other tests.","summary":"Floretyrosine F 18 (Pixclara; Telix Pharmaceuticals (US) Inc.) was approved by the FDA on 11 September 2026 as a novel drug, for use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and children aged 1 month and older. It is given as a single injection into a vein. The label describes two studies: a prospective single-centre study (NCT04044937) whose image analysis included 127 patients with suspected recurrent or progressive glioma of any grade, 116 of them adults, read blind by three nuclear medicine experts against a composite reference standard set by an expert panel; and a blinded central read of images collected in routine practice at several centres.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA: Novel drug approvals for 2026","url":"https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026"},{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dc78b128-3768-4448-b019-61574db05714"},{"label":"US label at approval (FDA, NDA 218592)","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218592Orig1s000lbl.pdf"}],"tags":["universe-gap","fda-novel","diagnostic"],"related":["fluciclovine-f18"],"cancers":["glioblastoma","idh-mutant-astrocytoma","oligodendroglioma","paediatric-high-grade-glioma","paediatric-low-grade-glioma"],"sections":[],"technologies":["pet"],"targets":[],"drugs":[],"companies":["telix"],"institutions":[],"pathways":[],"terms":["radiation-necrosis"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo universe gaps (EMA register, FDA novel approvals, WHO eEML)","editedOn":"2026-11-03"},"brand":"Pixclara","modality":"PET radiotracer (radiolabelled amino acid)","mechanism":"A radiolabelled form of the amino acid tyrosine, carried into cells by the large neutral amino acid transporters (LAT), which are highly expressed at the blood-brain barrier and in glioma tissue, so the tracer builds up in tumour; fluorine-18 emits positrons for PET imaging (US label, section 12.1).","approvals":[{"region":"US","year":2026,"indication":"PET to differentiate recurrent or progressive glioma from treatment-related change, with other diagnostic evaluations, in adults and children 1 month and older","note":"FDA novel drug approval 11 Sep 2026; NDA 218592; Telix"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/floretyrosine-f18/","neighbours":{"drug":[{"id":"fluciclovine-f18","kind":"drug","name":"Fluciclovine F-18","route":"/drugs/fluciclovine-f18/"}],"cancer":[{"id":"idh-mutant-astrocytoma","kind":"cancer","name":"Astrocytoma, IDH-mutant (grades 2 to 4)","route":"/cancers/idh-mutant-astrocytoma/"},{"id":"glioblastoma","kind":"cancer","name":"Glioma & glioblastoma","route":"/cancers/glioblastoma/"},{"id":"oligodendroglioma","kind":"cancer","name":"Oligodendroglioma, IDH-mutant and 1p/19q-codeleted","route":"/cancers/oligodendroglioma/"},{"id":"paediatric-high-grade-glioma","kind":"cancer","name":"Paediatric high-grade glioma (excluding diffuse midline glioma)","route":"/cancers/paediatric-high-grade-glioma/"},{"id":"paediatric-low-grade-glioma","kind":"cancer","name":"Paediatric low-grade glioma","route":"/cancers/paediatric-low-grade-glioma/"}],"technology":[{"id":"pet","kind":"technology","name":"PET (positron emission tomography)","route":"/technologies/pet/"}],"company":[{"id":"telix","kind":"company","name":"Telix Pharmaceuticals","route":"/companies/telix/"}],"term":[{"id":"radiation-necrosis","kind":"term","name":"Radiation necrosis (brain)","route":"/terms/radiation-necrosis/"}]}}