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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.
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.
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).
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
| Region | Year | Indication |
|---|---|---|
| US | 2026 | PET to differentiate recurrent or progressive glioma from treatment-related change, with other diagnostic evaluations, in adults and children 1 month and older · FDA novel drug approval 11 Sep 2026; NDA 218592; Telix |
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Query for this drug: (TITLE:"Floretyrosine F 18" OR ABSTRACT:"Floretyrosine F 18" OR TITLE:"Pixclara" OR ABSTRACT:"Pixclara" OR TITLE:"floretyrosine F 18" OR ABSTRACT:"floretyrosine F 18" OR TITLE:"floretyrosine F18" OR ABSTRACT:"floretyrosine F18" OR TITLE:"floretyrosine" OR ABSTRACT:"floretyrosine") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Floretyrosine F 18, not a curated reading list.
Shares PET (positron emission tomography) and the tags universe-gap, diagnostic.
Shares the tags universe-gap, diagnostic.
Shares Fluciclovine F-18, Glioma & glioblastoma.
Shares PET (positron emission tomography) and the tag diagnostic.
Shares Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, Astrocytoma, IDH-mutant (grades 2 to 4), Paediatric high-grade glioma (excluding diffuse midline glioma), Glioma & glioblastoma.
Shares Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, Astrocytoma, IDH-mutant (grades 2 to 4), Glioma & glioblastoma.
Shares Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, Astrocytoma, IDH-mutant (grades 2 to 4), Paediatric high-grade glioma (excluding diffuse midline glioma).
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