FDA Grants Fast Track Designation for Telix's BiPASS Program in Prostate Cancer Diagnosis

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Telix Pharmaceuticals’ BiPASS® program, which is investigating the use of 68Ga-PSMA-PET imaging in conjunction with MRI for pre-biopsy prostate cancer diagnosis. This designation aims to expedite the development of diagnostic tools that address significant unmet medical needs in prostate cancer detection.

BiPASS (Biopsy of the Prostate Avoidance Stratification Study) evaluates the effectiveness of gallium-68 (68Ga) PSMA-PET imaging alongside MRI to improve diagnostic accuracy before the invasive biopsy procedure. Fast Track designation facilitates closer communication with the FDA and may accelerate the review of the New Drug Application (NDA) process, potentially increasing patient access to these diagnostic technologies upon approval.

Currently, over three million prostate biopsies are performed worldwide each year, with as many as 75% yielding negative results, illustrating the need for improved diagnostic methodologies. Prostate biopsies can be stressful and painful, frequently providing little meaningful diagnostic information, which underscores the importance of enhancing diagnostic pathways.

Telix has completed patient enrollment in the Phase 3 BiPASS study, which assesses its proprietary 68Ga-PSMA-PET agents, Illuccix® and Gozellix®, for the diagnosis of prostate cancer preceding biopsy. The FDA has been engaged regarding the NDA pathway, with plans for submission in the works. If the NDA is approved, it may expand access to 68Ga-PSMA-PET imaging for a larger cohort of patients.

The BiPASS study builds on insights gained from the PRIMARY and PRIMARY2 studies, which indicated that combining 68Ga-PSMA-PET imaging with MRI may enhance the detection of clinically significant prostate cancer and significantly reduce unnecessary biopsies.

Dr. David N. Cade, Group Chief Medical Officer at Telix, expressed that the FDA’s Fast Track designation highlights the agency's acknowledgment of BiPASS's potential to alleviate a critical unmet need in prostate cancer diagnostics. He emphasized that the collaboration could enhance decision-making prior to biopsy and improve patient outcomes by potentially decreasing the number of unnecessary invasive procedures.

Both Illuccix and Gozellix are approved for imaging PSMA-positive lesions in patients with prostate cancer who either are candidates for initial definitive therapy or are suspected of recurrence based on elevated serum prostate-specific antigen (PSA) levels. However, their application in the pre-biopsy setting remains investigational and lacks approval from the FDA or other regulatory bodies.