By Digifin Pty Ltd · About this coverage
Key Points
- FDA Fast Track granted for BiPASS 68Ga-PSMA-PET plus MRI pre-biopsy prostate imaging
- Phase 3 BiPASS enrollment completed for Illuccix and Gozellix; NDA pathway under discussion
- PRIMARY studies cited as cutting unnecessary biopsies by almost 50 percent with PET plus MRI
- Fast Track may allow more frequent FDA engagement and expedited review of a planned NDA
- Pre-biopsy use of Illuccix and Gozellix remains investigational and is not approved
About Telix (ASX:TLX)
Telix Pharmaceuticals Limited is an ASX-listed radiopharmaceutical company headquartered in Melbourne. It develops and commercialises precision diagnostics and targeted radiopharmaceutical therapies for cancer, with operations across North America, Europe, Latin America and Asia-Pacific.
Telix (ASX:TLX) said the US Food and Drug Administration has granted Fast Track designation for its BiPASS program, which is evaluating gallium-68 PSMA-PET imaging alongside MRI for prostate cancer detection before biopsy.
BiPASS (Biopsy of the Prostate Avoidance Stratification Study) uses Telix's proprietary 68Ga-PSMA-PET agents Illuccix and Gozellix in the pre-biopsy setting. Fast Track is intended to facilitate development and expedite review of drugs for serious conditions that fill an unmet medical need, and may enable more frequent FDA engagement and expedited review of a planned new drug application. Telix has completed enrollment in the Phase 3 BiPASS study and says it has engaged with the FDA on an NDA pathway and is planning its submission. The company cites PRIMARY and PRIMARY2 studies as showing that combining 68Ga-PSMA-PET with MRI can improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50 percent. BiPASS is not intended to replace biopsy when it benefits the patient, but to help decide which patients would benefit and where biopsy should be targeted.
Use of Illuccix and Gozellix in the pre-biopsy setting remains investigational and is not approved by the FDA or any other regulator. An NDA has not yet been submitted.
Source: Telix Pharmaceuticals Limited (ASX:TLX), 30 September 2026. Summary content supplied by Digifin Pty Ltd.
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