Telix Pharmaceuticals announced on September 30, 2026, that the US Food and Drug Administration (FDA) granted Fast Track designation to its BiPASS program, which is evaluating gallium-68 (^68Ga) PSMA-PET imaging in combination with magnetic resonance imaging (MRI) before prostate biopsy.
The designation recognizes the program’s potential to address an unmet need in the initial prostate cancer diagnostic pathway. According to Telix, Fast Track status may facilitate more frequent engagement with the FDA and could support expedited review of the planned new drug application (NDA).
Telix recently completed enrollment in the phase 3 BiPASS study and stated that it has already engaged with the FDA regarding an NDA pathway and is planning its submission.
What Is BiPASS?
BiPASS, or the Biopsy of the Prostate Avoidance Stratification Study, is a prospective, open-label phase 3 trial evaluating Telix’s commercial ^68Ga-PSMA-PET imaging agents Illuccix and Gozellix in the initial prostate cancer diagnosis setting. The study was designed to assess the use of PSMA-PET before biopsy and enrolled patients at sites in the United States and Australia.
The trial evaluates whether combining MRI with Illuccix/Gozellix ^68Ga-PSMA-11 PET can improve diagnostic accuracy and reduce unnecessary biopsies compared with current standard practice. The objective is to integrate molecular imaging earlier in the diagnostic pathway to improve lesion detection and patient stratification. This approach may allow biopsy de-escalation in some patients or greater biopsy precision when biopsy is performed.
Importantly, BiPASS is not intended to replace biopsy when biopsy is clinically appropriate. Rather, the program aims to help clinicians determine which patients may benefit from biopsy and where biopsy should be targeted. BiPASS is registered as ClinicalTrials.gov study NCT07052214.
Why BiPASS Is Being Evaluated
According to Telix, more than 3 million prostate biopsies are performed globally each year, while up to 75% yield a negative result. The company also notes that prostate biopsy can be stressful and painful and may provide no meaningful diagnostic benefit in some patients.
In its earlier BiPASS announcement, Telix reported that more than 1 million prostate biopsies are performed annually in the United States and that up to 75% are negative. The company described the study as an effort to integrate noninvasive molecular imaging earlier in the diagnostic pathway to improve lesion detection and patient stratification.
The BiPASS program builds on the clinical foundation established by the PRIMARY and PRIMARY2 studies. Telix stated that these studies demonstrated that combining ^68Ga-PSMA-PET imaging with MRI could improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50%.
The earlier BiPASS description similarly states that PRIMARY and PRIMARY2 demonstrated that MRI combined with ^68Ga-PSMA-11 PET can better define or rule out prostate cancer and guide active surveillance before invasive biopsy.
What the FDA Fast Track Designation Means
FDA Fast Track designation is intended to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. For BiPASS, Telix stated that the designation will support continued close engagement with the FDA as the company advances the program toward an NDA submission.
David N. Cade, Group Chief Medical Officer at Telix, said the designation reflects the FDA’s recognition of the potential for BiPASS to address an unmet need in the prostate cancer diagnostic pathway. He noted that using ^68Ga-PSMA-PET alongside MRI could help physicians make more informed decisions before biopsy, improve diagnostic confidence, and potentially reduce unnecessary invasive procedures.
Current Regulatory Status of Illuccix and Gozellix
Illuccix and Gozellix are already FDA-approved for PET imaging of PSMA-positive lesions in patients with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, as well as in patients with suspected recurrence based on an elevated serum prostate-specific antigen level. Illuccix is also approved for the selection of patients indicated for PSMA-directed therapy.
However, the use of both agents in the pre-biopsy setting remains investigational and has not been approved by the FDA or any other regulatory authority. This distinction is important because the FDA action announced on September 30 is a Fast Track designation for the BiPASS development program, not an approval of Illuccix or Gozellix for pre-biopsy prostate cancer diagnosis.
Takeaway
The FDA has granted Fast Track designation to Telix’s BiPASS program evaluating ^68Ga-PSMA-PET imaging together with MRI before prostate biopsy. The phase 3 study is designed to determine whether introducing PSMA-PET earlier in the diagnostic pathway can improve diagnostic accuracy, reduce unnecessary biopsies, and improve biopsy targeting when biopsy is required.
With phase 3 enrollment completed and an NDA submission planned, the Fast Track designation may support closer regulatory interaction as Telix advances the program. The pre-biopsy use of Illuccix and Gozellix remains investigational.
