FDA Approves Telix Pixclara for Glioma Imaging

Telix (ASX:TLX) has received U.S. Food and Drug Administration approval of its New Drug Application for Pixclara (floretyrosine F 18 or 18F-FET), making it the first FDA-approved FET-PET imaging drug for glioma.

Pixclara is a radioactive diagnostic drug indicated 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 pediatric patients 1 month of age and older. FET-PET imaging is recommended in international clinical practice guidelines, including NCCN Guidelines, but until now there has not been an FDA-approved product available in the U.S. Gliomas account for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors, with approximately 24,000 new glioma cases diagnosed each year in the U.S. Pixclara (TLX101-Px) is also the subject of a Phase 3 registrational study for potential indication expansion for the diagnosis of brain metastases.

The release does not disclose U.S. launch timing, pricing or expected revenue from Pixclara. Telix's late-stage therapeutic candidates TLX591-Tx, TLX101-Tx and TLX250-Tx have not received marketing authorizations in any jurisdiction.