Telix’s BiPASS program receives FDA Fast Track designation for PSMA-PET and MRI-based prostate cancer imaging before biopsy.
Written By: Rishabh Sonawane, BPharm
Reviewed By: Pharmacally Editorial Team
Telix Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for its BiPASS® program, which is evaluating gallium-68 (^68Ga) prostate-specific membrane antigen positron emission tomography (PSMA-PET) combined with magnetic resonance imaging (MRI) for prostate cancer detection before biopsy.
The designation recognizes the program’s potential to address an unmet need in the diagnostic pathway and may facilitate more frequent interactions with the FDA during development. Fast Track designation can also support expedited review of a future regulatory application, although it does not guarantee FDA approval or a specific review outcome.
BiPASS, or Biopsy of the Prostate Avoidance Stratification Study, is designed to evaluate whether imaging can help identify which patients are most likely to benefit from prostate biopsy and determine where biopsy should be targeted. Telix has completed enrollment in the Phase 3 BiPASS study (NCT07052214) and has engaged with the FDA regarding the planned NDA pathway.
BiPASS builds on previous imaging evidence
The Phase 3 BiPASS program follows the PRIMARY and PRIMARY2 studies, which evaluated ^68Ga-PSMA-PET combined with MRI in the pre-biopsy setting. According to Telix, these studies demonstrated improved detection of clinically significant prostate cancer while reducing unnecessary prostate biopsies by almost 50%.
The approach is intended to support better patient selection before an invasive procedure rather than eliminate biopsy when tissue sampling remains clinically appropriate. By combining molecular imaging with MRI, the program is investigating whether imaging can provide additional information to guide biopsy decisions and targeting.
The potential clinical relevance of this approach is underscored by the burden associated with prostate biopsy. Telix cites more than three million prostate biopsies performed globally each year, with up to 75% producing a negative result. An imaging-based approach could therefore provide an additional method for stratifying patients before biopsy, subject to the outcome of the Phase 3 study and regulatory review.
Illuccix and Gozellix remain investigational for pre-biopsy use
Telix’s ^68Ga-PSMA-PET agents Illuccix® (kit for the preparation of gallium-68 gozetotide injection) and Gozellix® are already approved for specified PSMA-PET imaging uses in prostate cancer.
These approved uses include imaging in patients with prostate cancer with suspected metastasis and suspected recurrence. Illuccix is also approved for selecting patients for PSMA-directed therapy.
However, the pre-biopsy use of Illuccix and Gozellix remains investigational. Neither product has been approved by the FDA or another regulatory authority for the proposed pre-biopsy prostate cancer diagnostic indication.
An eventual approval for this setting could expand the clinical use of ^68Ga-PSMA-PET imaging by providing an additional imaging-based approach for evaluating patients before biopsy.
NDA submission is the next regulatory milestone
With BiPASS enrollment completed, Telix is planning an NDA submission following its engagement with the FDA regarding the regulatory pathway.
If submitted and accepted, the application would undergo FDA review based on the clinical and other supporting evidence included in the submission. The Fast Track designation may facilitate continued communication with the agency and potentially support expedited review, but it does not guarantee approval.
For the proposed pre-biopsy indication, the FDA’s assessment will depend on the Phase 3 BiPASS results and the totality of evidence submitted with the application. Until regulatory authorization is granted, the use of Illuccix or Gozellix for pre-biopsy prostate cancer diagnosis remains investigational.
The BiPASS program therefore represents a further development of PSMA-PET imaging into the earlier diagnostic pathway for prostate cancer, with its potential clinical role ultimately dependent on Phase 3 evidence and regulatory review.
Reference
Telix Granted FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Cancer Imaging, Telix, 30 September 2026
PSMA PET Combined with MRI for the Detection of PCa (BiPASS), ClinicalTrials.gov ID NCT07052214
PSMA PET Additive Value for Prostate Cancer Diagnosis in Men with Negative/Equivocal MRI (PRIMARY2), ClinicalTrials.gov ID NCT05154162
About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.