The United States Food and Drug Administration has granted Telix Pharmaceuticals Fast Track designation for its BiPASS program. The decision could shorten the path to market for a scan designed to help men avoid prostate biopsies they may not need.
The Melbourne-headquartered radiopharmaceutical company said the FDA recognised the program's potential to meet an important unmet need. BiPASS stands for the Biopsy of the Prostate Avoidance Stratification Study. It is testing whether a gallium-based PET scan that targets prostate-specific membrane antigen, known as PSMA, can be used with MRI to detect prostate cancer before a patient goes to biopsy.
More than three million prostate biopsies are performed around the world each year, yet up to 75 per cent come back negative. The procedure can be stressful and painful for patients and may give them no meaningful diagnostic benefit.
Fast Track is an FDA process that speeds up the development and review of drugs for serious conditions with an unmet medical need.
Telix recently finished enrolling patients in the Phase 3 BiPASS study of its PSMA imaging agents, Illuccix and Gozellix. The company says it has positively engaged with the FDA on a new drug application pathway and is planning its submission. If approved, registration as a new product would make this imaging approach available to a much larger group of patients.
The trial builds on the earlier PRIMARY and PRIMARY2 studies. Those studies found that pairing PSMA PET with MRI significantly improved detection of clinically significant prostate cancer while cutting unnecessary biopsies by almost half. Telix says BiPASS is not meant to replace biopsy where it benefits the patient. Instead, it aims to help clinicians determine which patients need a biopsy and where to target it.
"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 Dr David N. Cade, Telix's Group Chief Medical Officer.
"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."
Illuccix and Gozellix are already approved for PET imaging of PSMA-positive lesions in two groups of men with prostate cancer. The first is men with suspected metastasis who are candidates for initial definitive therapy. The second is men with suspected recurrence based on an elevated prostate-specific antigen level. Illuccix is also approved for selecting patients for PSMA-directed therapy and is sold in 22 countries, including the United States. Using either agent before biopsy is still investigational and has not been approved by the FDA or any other regulator.
