Telix Secures FDA Fast Track For BiPASS Prostate Cancer Program

An NDA pathway for a kit-based radiopharmaceutical in a pre-biopsy indication carries manufacturing and compliance weight that extends well beyond the clinical data package, and Telix Pharmaceuticals' FDA Fast Track designation for its BiPASS program now puts that pathway on an accelerated timeline. The designation, granted for the evaluation of 68Ga-PSMA-PET imaging alongside MRI in initial prostate cancer diagnosis, enables more frequent FDA engagement and may support expedited review of the planned NDA submission.

BiPASS (Biopsy of the Prostate Avoidance Stratification Study) uses Telix's proprietary agents Illuccix and Gozellix, both kit-based preparations of gallium Ga68 gozetotide injection, in a Phase 3 study that has now completed enrollment. The NDA pathway, rather than a supplemental application, signals registration as a new product, which would expand the approved indication beyond the current metastatic and recurrence settings into the substantially larger pre-biopsy population.

For manufacturing and QA leads, the kit-based radiopharmaceutical format introduces specific GMP considerations: short-lived radionuclide handling, point-of-use radiolabeling, and the sterility assurance requirements that accompany aseptic processing under 21 CFR Part 211. An NDA submission for this class of agent will require a chemistry, manufacturing, and controls package that reflects both the complexity of the radiolabeling process and the scalability demands of a broader commercial indication. Facilities supporting 68Ga production will need to demonstrate process validation across the full intended commercial scale, not merely the volumes used in the Phase 3 setting.

The clinical rationale is grounded in prior data. The PRIMARY and PRIMARY2 studies demonstrated that combining 68Ga-PSMA-PET with MRI improved detection of clinically significant prostate cancer and reduced unnecessary biopsies by close to 50 percent. With more than three million prostate biopsies performed globally each year, and up to 75 percent returning negative results, the diagnostic gap the program targets is measurable and well-documented.

Illuccix and Gozellix currently hold FDA approval for PET imaging of PSMA-positive lesions in metastatic and recurrence settings; use in the pre-biopsy setting remains investigational. Fast Track status does not alter that regulatory standing, but it does compress the engagement cycle with the agency ahead of submission.

The NDA submission timeline and the agency's response to the CMC package will be the next measurable checkpoint for operations and regulatory teams tracking this program.

Source: Telix Pharmaceuticals Limited via telixpharma.com, September 30, 2026.