Years After NCCN Recommended It, FET-PET Finally Has an FDA-Approved Drug
- The FDA approved Telix Pharmaceuticals‘ new drug application for Pixclara (floretyrosine F 18, or 18F-FET) on 14 September 2026. It is a radioactive diagnostic indicated for use with PET to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and paediatric patients from 1 month of age.
- The clinical case was settled before the regulatory one. FET-PET imaging is already recommended for glioma in NCCN Guidelines and in joint guidance from the European Association of Nuclear Medicine, EANO, SNMMI and RANO published in Lancet Oncology in 2025. No FDA-approved product existed in the US to act on those recommendations.
- This followed a resubmission. The FDA accepted Telix’s resubmitted NDA earlier in 2026 and set a PDUFA goal date of 11 September, with approval landing three days later.
- Safety was evaluated in 382 glioma patients. Headache occurred in 0.5%, with nausea, injection site reaction, fatigue and malaise each below that. The label carries warnings on image misinterpretation and cumulative radiation exposure. Roughly 24,000 new glioma cases are diagnosed in the US each year.
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The guidelines got there first. NCCN and the joint European and American societies already recommend FET-PET for exactly this question, so American clinicians have held the recommendation without a lawful product to act on it.
- This approval closes a recommendation gap rather than creating a practice. Telix inherits a guideline-endorsed indication instead of having to build one, which removes the usual adoption problem for a novel tracer. The 2025 joint society guidance did the clinical persuasion years ahead of the regulatory filing.
- The label’s risk is interpretation, not toxicity. Across 382 patients the only adverse reaction reaching 0.5% was headache. The warnings cover image misinterpretation and cumulative radiation, so the failure mode here is a misread scan, which is a reading-standard and training problem rather than a pharmacological one.
- Payment is the unanswered question and the release does not touch it. Uptake of a PET tracer turns on whether it draws separate payment alongside the scan or gets absorbed into it. Against roughly 24,000 new US cases a year, that determination moves volume more than the approval does.
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CompaniesTelix Pharmaceuticals