Telix completes BiPASS enrolment and aligns with FDA on NDA path
Telix Pharmaceuticals has completed patient enrolment in the Phase 3 BiPASS study, which is evaluating its 68Ga-PSMA-PET imaging agents Illuccix and Gozellix in men with suspected prostate cancer ahead of biopsy. A total of 350 participants were enrolled across sites in the United States and Australia in the prospective, open-label trial. The company has also confirmed alignment with the FDA on a New Drug Application pathway for the indication, a step that, if successful, would establish a new reimbursement category and meaningfully extend patient access to gallium-based PSMA-PET imaging.
BiPASS (Biopsy of the Prostate Avoidance Stratification Study) is described by Telix as the first registrational study of 68Ga-PSMA-PET imaging in the pre-biopsy setting. Current approved indications for Illuccix and Gozellix are limited to initial staging and biochemical recurrence in men already diagnosed with prostate cancer. If BiPASS meets its primary objectives, the dataset would support a regulatory filing to extend labelling into the diagnostic workup phase, before a biopsy decision is made.
Clinical rationale
The trial builds on two predecessor studies. The PRIMARY trial, published in European Urology in 2021, and PRIMARY2, reported in The Lancet Oncology earlier this year, both demonstrated that combining 68Ga-PSMA-PET with MRI could detect clinically significant prostate cancer while cutting unnecessary biopsies by close to half. Telix is positioning BiPASS as the registrational confirmatory study that translates those academic findings into a labelled, reimbursable clinical pathway.
The clinical need is substantial. More than three million prostate biopsies are performed globally each year, according to a 2024 JAMA Oncology analysis cited in the release, yet published data suggest up to 75% return negative results. Patient compliance is a parallel problem, with roughly one in four men declining a physician recommendation to undergo biopsy, citing pain, anxiety and procedural risk. A validated pre-biopsy imaging step that reliably identifies who genuinely needs tissue sampling could reduce that burden considerably.
Professor Louise Emmett, Director of Theranostics and Nuclear Medicine at St Vincent's Hospital and a BiPASS investigator, said: "BiPASS now has the potential to fundamentally change the current standard of care, streamlining the diagnostic pathway, accelerating treatment decision-making and helping to ensure that men receive the most appropriate therapy earlier in their treatment journey."
Market and competitive context
The PSMA-PET imaging market has grown rapidly since the first US approvals in 2022, with Lantheus Holdings' Pylarify (piflufolastat F18) and Blue Earth Diagnostics' Posluma (flotufolamod F18) competing alongside Telix's gallium-based agents. Fluorine-18 tracers offer a longer half-life and do not require an on-site cyclotron, which can simplify logistics for some centres. Telix's gallium agents, by contrast, have an established commercial footprint in markets where gallium-68 generator infrastructure is already in place, and the company reports that Illuccix is now commercially available in 22 countries.
A positive BiPASS readout and subsequent NDA approval would open a pre-biopsy indication currently unoccupied by any approved radiopharmaceutical, potentially differentiating Telix's portfolio in a market that would otherwise remain a straight-line competition on price and logistics. The company did not provide a projected trial readout timeline in the announcement; investors and analysts will be looking for a data disclosure date as the next catalyst. Telix's broader late-stage pipeline includes lutetium-177 therapeutic candidates in prostate cancer, glioblastoma and kidney cancer, meaning the diagnostic and therapeutic arms of its theranostics strategy are advancing in parallel.