FDA Approves Telix's Pixclara, First FET-PET Imaging Drug for Glioma in the U.S.
核心洞察
The FDA approved Telix Pharmaceuticals' Pixclara (floretyrosine F 18 (搜索)), the first FDA-approved FET-PET imaging drug for glioma (搜索) in the United States.
Pixclara is indicated to differentiate recurrent or progressive glioma (搜索) from treatment-related change in adults and pediatric patients aged 1 month and older.
Approval followed an April 2025 Complete Response Letter and a March 2026 resubmission incorporating additional analyses of existing clinical data.
The U.S. Food and Drug Administration has approved Pixclara (floretyrosine F 18 (搜索), or ¹⁸F-FET), an amino acid positron emission tomography (PET) imaging drug for glioma (搜索), Telix Pharmaceuticals announced on September 14, 2026. The approval makes Pixclara the first FDA-approved FET-PET imaging drug for glioma in the United States, and the only FDA-approved radiopharmaceutical imaging drug for the indication.
Pixclara is a radioactive diagnostic drug indicated for use with PET to differentiate recurrent or progressive glioma (搜索) from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older. FET-PET imaging is recommended in international clinical practice guidelines for glioma imaging, including NCCN Guidelines, but no FDA-approved FET-PET product had previously been available in the U.S.
Addressing a Diagnostic Challenge After Treatment
A central challenge in glioma (搜索) follow-up is determining whether new or increasing abnormalities after treatment represent recurrent or progressive tumor or changes caused by prior therapy. Treatment-related effects, including radiation-associated changes, can resemble tumor progression on conventional imaging. MRI remains central to glioma follow-up, but post-treatment changes can be difficult to distinguish from recurrent disease.
Amino acid PET has been investigated as a complementary imaging approach that may provide additional information when MRI findings are equivocal. Unlike conventional anatomical imaging, amino acid PET provides functional information related to amino acid transport and tumor activity.
Following intravenous administration, floretyrosine F 18 (搜索) is transported through amino acid transport systems, including L-type amino acid transporters LAT1 and LAT2 (搜索). The fluorine-18 radioisotope then enables areas of increased tracer uptake to be visualized on PET imaging. Telix describes the agent as comprising a small molecule targeting compound labeled with the diagnostic radioisotope fluorine-18, which targets membrane transport proteins LAT1 and LAT2; once bound, energy emissions from the radioisotope can be detected by a PET scanner.
Regulatory Path Included a Complete Response Letter
The approval follows a longer regulatory pathway. In April 2025, the FDA issued Telix a Complete Response Letter for its original New Drug Application, determining that the submitted evidence did not, at that stage, provide substantial evidence of effectiveness and requesting additional confirmatory evidence. Following subsequent discussions with the FDA, Telix developed a resubmission package incorporating additional analyses of existing clinical data. The company resubmitted the application in March 2026, and the FDA accepted the application for review the following month.
Safety Data From 382 Patients
The safety of Pixclara was evaluated in 382 patients with gliomas. Among them, 371 adult patients received at least one intravenous dose at a mean activity of 204 ± 18 MBq (5.5 ± 0.47 mCi), while 11 pediatric patients received at least one intravenous dose at a mean activity of 155 ± 53.5 MBq (4.2 ± 1.4 mCi). The mean age of patients was 57 years (range: 5 years to 86 years); 59% were male, 37% female, and 3% unreported.
Adverse reactions occurring in at least 0.5% of patients receiving Pixclara were headache (0.5%). Adverse reactions occurring in less than 0.5% of patients were nausea, injection site reaction, fatigue, and malaise. The safety profile observed in pediatric patients was consistent with that in adults.
The prescribing information includes warnings and precautions for risk of misinterpretation and radiation risks. A negative image does not rule out the presence of recurrent or progressive glioma (搜索), and a positive image does not confirm it; equivocal findings, including low-level or atypical uptake patterns, may result in false positive or false negative interpretations. Telix advises that findings be interpreted with caution and correlated with available clinical evaluations such as histopathology, cross-sectional imaging, and/or clinical history. The agent contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer; patients should be advised to hydrate before and after administration and to void frequently afterward.
Expert Reaction
Kevin Richardson, Chief Executive Officer of Telix Precision Medicine, said the approval will enable broad access in the U.S. to FET-PET imaging, which is already recognized in international clinical practice guidelines. "As the first FDA-approved PET imaging drug for glioma (搜索), Pixclara will provide physicians in the U.S. with more certainty in their diagnoses and greater confidence in their treatment planning for patients," he said.
Kelly Sitkin, President and CEO of the American Brain Tumor Association (搜索), said the approval will advance glioma (搜索) 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," Sitkin said.
Patrick Wen, MD, E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, said, "Having an FDA-approved FET-PET product with high diagnostic accuracy will make a significant, positive difference to the management of patients with gliomas. This is a very positive step forward for brain cancer imaging and treatment planning."
Disease Burden and Unmet Need
Gliomas are the most common form of central nervous system cancer, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors. In the U.S., approximately 24,000 new glioma (搜索) cases are diagnosed each year, representing a significant unmet addressable need.
Broader Development in Neuro-Oncology
Telix is also investigating Pixclara (TLX101-Px (搜索)) in a Phase 3 registrational study for potential indication expansion into the diagnosis of brain metastases (搜索). That indication remains investigational and is not included in the current FDA approval.
Separately, Telix is developing TLX101-Tx (搜索) (¹³¹I-iodofalan) as an investigational targeted radiopharmaceutical therapy for recurrent glioblastoma (搜索); the therapeutic candidate has not received marketing authorization. Telix's late-stage therapeutic pipeline also includes TLX591-Tx (lutetium-177 rosopatamab tetraxetan) in prostate cancer and TLX250-Tx (lutetium-177 girentuximab tetraxetan) in kidney cancer, none of which have received marketing authorizations in any jurisdiction. The company's precision diagnostics portfolio includes Illuccix and Gozellix (kits for the preparation of gallium-68 gozetotide injection), with Illuccix commercially available in 22 countries including the U.S. and Gozellix approved by the FDA for prostate imaging.