Telix finishes enrollment in Phase 3 BiPASS trial, aligns with FDA on NDA path
Telix Pharmaceuticals completed enrollment of 350 patients in its Phase 3 BiPASS study of Illuccix and Gozellix and reached agreement with the FDA on a New Drug Application route for pre-biopsy imaging use.
Telix Pharmaceuticals Limited said on September 2, 2026 that it had completed patient enrollment in the Phase 3 BiPASS study of its commercial PSMA-PET imaging agents, Illuccix and Gozellix, for prostate cancer imaging in the pre-biopsy setting.1 The company also said it had aligned with the FDA on a New Drug Application pathway for BiPASS that, if approved, would support reimbursement as a new product and broaden patient access.1
BiPASS, formally the "Biopsy of the Prostate Avoidance Stratification Study," is described as the first registrational study of 68Ga-PSMA-PET imaging in the pre-biopsy setting.1 The trial is designed to evaluate whether the combination of MRI and PSMA-PET/CT with Telix's proprietary 68Ga-PSMA-PET agents can help sharpen diagnostic accuracy, cut down on unnecessary biopsies, or better guide where biopsies are taken, compared with current practice.1 A total of 350 patients were enrolled in the U.S. and Australia in this prospective, open-label Phase 3 trial.1
Telix framed the study against a backdrop in which more than three million prostate biopsies are performed globally each year, yet up to 75% are found negative, and roughly one in four patients decline a physician's recommendation to undergo biopsy.1 The company noted that biopsy is often stressful and painful, may lead to complications, and offers no real diagnostic benefit for many patients.1
Telix said BiPASS builds on two earlier studies, PRIMARY and PRIMARY2, which the company said showed that pairing 68Ga-PSMA-PET imaging with MRI meaningfully improved detection of clinically significant prostate cancer while cutting unnecessary biopsies by nearly half.1 If BiPASS meets its goals, Telix said the combined data could help expand gallium-based PSMA-PET use from its current roles in initial staging and recurrence monitoring into a broader role in initial cancer diagnosis, according to the company's characterization of the drug's potential rather than a confirmed regulatory outcome.
No specific timeline for topline data or FDA filing was given in the release.
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