FDA grants fast track designation to pre-biopsy 68Ga-PSMA-PET program

The FDA has granted Fast Track designation to Telix Pharmaceuticals’ BiPASS program, a phase 3 study evaluating gallium-68 (⁶⁸Ga) prostate-specific membrane antigen (PSMA)-PET in combination with prostate MRI before prostate biopsy.¹

The designation comes after completion of enrollment in BiPASS and as Telix prepares a potential new drug application (NDA) for the pre-biopsy use of its ⁶⁸Ga-PSMA imaging agents Illuccix and Gozellix. Illuccix and Gozellix are kits used to prepare gallium Ga 68 gozetotide, also known as ⁶⁸Ga-PSMA-11, a PSMA-targeting diagnostic agent.

Fast Track designation is intended to facilitate development and expedite review of drugs for serious conditions that address an unmet medical need. The designation can provide more frequent interactions with the FDA during development and eligibility for accelerated approval and priority review.²

“Fast Track designation reflects the FDA’s recognition of the potential for BiPASS to address an important unmet need in the prostate cancer diagnostic pathway,” said David N. Cade, MBBS, MBA, Group Chief Medical Officer at Telix, in a news release from the company.¹ “We believe gallium-68 PSMA-PET, used alongside MRI, could help physicians make more informed decisions before biopsy, improve diagnostic confidence, and potentially reduce unnecessary invasive procedures for patients. This designation supports continued close engagement with the FDA as we advance BiPASS toward an NDA submission.”

BiPASS trial overview

BiPASS (NCT07052214) is a prospective, open-label, multicenter, phase 3 study being conducted at sites in the US and Australia.³ The program is evaluating whether adding ⁶⁸Ga-PSMA-PET to MRI can improve identification of clinically significant prostate cancer (csPCa), help determine which patients should undergo biopsy, and direct biopsy toward suspicious lesions.

The study enrolled 350 patients, according to Telix.⁴ Participants have clinical suspicion of prostate cancer after having received prostate MRI and/or enter the study based on nonimaging risk factors before biopsy.

The study is designed to evaluate the diagnostic performance of ⁶⁸Ga-PSMA-PET when used alongside MRI. Histopathology serves as the reference standard. The co-primary end points assess the sensitivity and specificity of ⁶⁸Ga-PSMA-PET as an adjunct to MRI for prostate cancer detection.

Completion of the study is expected in 2027.

Clinical context

BiPASS follows earlier prospective studies evaluating the role of ⁶⁸Ga-PSMA-PET in men with suspected prostate cancer. In the PRIMARY study, which included 291 men undergoing MRI triage, combining PSMA-PET with MRI increased sensitivity for csPCa detection from 83% with MRI alone to 97% (P < .001), although specificity decreased from 53% to 40% (P = .011).⁵ The combined approach classified 19% of participants as negative on both tests; 5 of 162 men with csPCa were missed.

More recently, the randomized phase 3 PRIMARY2 trial evaluated an imaging-based strategy in 660 biopsy-naive men with PI-RADS 2 or 3 MRI findings and additional clinical risk factors.⁶ Participants were assigned to systematic transperineal biopsy or ⁶⁸Ga-PSMA-11 PET/CT, with PET-positive patients undergoing targeted biopsy and PET-negative patients avoided biopsy. The PSMA-PET strategy avoided biopsy in 49% of participants while maintaining noninferior detection of csPCa: 12% in the PET group vs 16% in the control group (difference, −3.7%; 95% CI, −8.9% to 1.5%; P = .0093).

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REFERENCES

1. Telix granted FDA fast track designation for BiPASS pre-biopsy prostate cancer imaging. News release. Telix Pharmaceuticals. September 30, 2026. Accessed September 30, 2026. https://telixpharma.com/news-views/telix-granted-fda-fast-track-designation-for-bipass-pre-biopsy-prostate-cancer-imaging/

2. Fast track. US Food & Drug Administration. Accessed September 30, 2026. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

3. PSMA PET combined with MRI for the detection of PCa (BiPASS). ClinicalTrials.gov. Last updated July 23, 2026. Accessed September 30, 2026. https://clinicaltrials.gov/study/NCT07052214

4. Telix completes enrollment in phase 3 BiPASS study, aligns with FDA on NDA pathway. News release. Telix Pharmaceuticals. September 1, 2026. Accessed September 30, 2026. https://telixpharma.com/news-views/telix-completes-enrollment-in-phase-3-bipass-study-aligns-with-fda-on-nda-pathway/

5. Emmett L, Buteau J, Papa N, et al. The additive diagnostic value of prostate-specific membrane antigen positron emission tomography computed tomography to multiparametric magnetic resonance imaging triage in the diagnosis of prostate cancer (PRIMARY): A prospective multicentre study. Eur Urol. 2021;80(6):682-689. doi:10.1016/j.eururo.2021.08.002

6. Buteau JP, Moon D, Fahey MT, et al. Effect of [68Ga]Ga-PSMA-11 PET-CT in the diagnosis of prostate cancer in men with equivocal or clinically high-risk non-suspicious findings on multiparametric MRI (PRIMARY2): a multicentre, non-inferiority, phase 3, randomised controlled trial. Lancet Oncol. 2026;27(7):839-848. doi:10.1016/S1470-2045(26)00120-8