FDA Approves TLX101-Px for PET Imaging in Patients With Glioma

The FDA has approved floretyrosine F 18 or ¹⁸F-FET (TLX101-Px; Pixclara), a radioactive diagnostic drug to be used with PET, for the characterization of recurrent or progressive glioma, according to a news release from Telix.¹ The approval follows a Prescription Drug User Fee Act (PDUFA) goal date of September 11, 2026, and marks the resolution of a regulatory process that began with an initial complete response letter (CRL) and a subsequent resubmission earlier in 2026.^2,3

Which indication TLX101-Px been approved for?

TLX101-Px is now approved for patients with recurrent of progressive glioma, allowing clinicians to better distinguish tumor progression from pseudoprogression, a treatment-related imaging change that can mimic recurrence on conventional MRI. Neuroimaging with 18F-FET is already broadly recommended in international clinical practice guidelines, including NCCN Guidelines®, for the evaluation of glioma.⁴

What is TLX101-Px and how does it work?

TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2), which are upregulated in glioma tissue. This mechanism allows the PET agent to help differentiate active tumor from treatment-related changes such as radiation necrosis or pseudoprogression. TLX101-Px may also serve as a patient selection and response assessment tool for Telix's LAT1-targeting therapeutic candidate, TLX101-Tx (iodofalan I 131), which is under investigation in the phase 3 IPAX-BrIGHT trial (NCT07100730) in patients with recurrent glioblastoma.⁵

The press release highlighted that TLX101-Px was assessed in 382 patients with glioma, with 371 receiving TLX101-Px at a mean activity of 204 ± 18 MBq (5.5 ± 0.47 mCi), while 11 pediatric patients were given at least 1 intravenous dose at 155 ± 53.5 MBq (4.2 ± 1.4 mCi).

Adverse effects were noted in 0.5% or more of patients, with 0.5% reporting headaches. For those that occurred in less than 0.5% of patients included nausea, injection site reaction, fatigue, and malaise.

What is TLX101-Px's regulatory history in glioma?

TLX101-Px was previously known as TLX101-CDx before its current designation. The agent has been granted both orphan drug designation and fast track designation by the FDA for the characterization of recurrent or progressive glioma from treatment-related changes.⁶ The FDA issued a complete response letter for the original application on April 28, 2025; at the time, Telix managing director and group CEO Christian Behrenbruch, PhD, stated in a release that the company was “committed to commercializing TLX101-CDx and fulfilling the unmet need to improve imaging to enable timelier and more accurate decisions for the clinical management of glioma.”² Telix resubmitted the NDA with additional data and statistical analyses on March 13, 2026.³ The FDA accepted the resubmission on April 10, 2026, and assigned a PDUFA goal date of September 11, 2026.

What's next for Telix's glioma imaging and therapy programs?

As of Telix's half-year 2026 results released August 20, 2026, the company reaffirmed the September 11, 2026 PDUFA goal date for TLX101-Px.⁷ A parallel marketing authorization application for TLX101-Px (Pixlumi®) was accepted in Europe on April 30, 2026, indicating a potential path to approval outside the US as well.⁸

References

1. FDA Approves Telix’s brain cancer imaging drug Pixclara. News release. Telix. September 14, 2026. Accessed September 14, 2026. https://tinyurl.com/2c27jrex
2. FDA accepts NDA for TLX101-Px (Pixclara®). News release. Telix. April 10, 2026. Accessed September 8, 2026. https://tinyurl.com/mrykd99c
3. Telix resubmits NDA to U.S. FDA for TLX101-Px (Pixclara) brain cancer imaging candidate. Telix Pharmaceuticals. March 16, 2026. Accessed September 8, 2026. https://tinyurl.com/43sts63h
4. Galldiks N, Albert NL, Sommerauer M, et al. Update to the RANO working group and EANO recommendations for the clinical use of PET imaging. Lancet Oncol. 2025;26(8):e436–e447. doi:10.1016/S1470-2045(25)00193-7.
5. Study of TLX101-Tx plus standard of care (SoC) versus SoC alone for the treatment of patients with recurrent glioblastoma (IPAX BrIGHT). ClinicalTrials.gov. Updated August 11, 2026. Accessed September 8, 2026. https://tinyurl.com/2fsh2czh
6. Telix provides regulatory update on TLX101-CDx. News release. Telix Pharmaceuticals Limited. April 28, 2025. Accessed September 8, 2026. https://tinyurl.com/2xyazvsy
7. Telix 2026 half-year results: strong commercial execution and momentum in late-stage pipeline. News release. Telix Pharmaceuticals Limited. August 20, 2026. Accessed September 8, 2026. https://tinyurl.com/k8cddv4h
8. TLX101-Px (Pixlumi®) MAA accepted in Europe. News release. Telix Pharmaceuticals Limited. April 30, 2026. Accessed September 8, 2026. https://tinyurl.com/hcdn7vyw