FDA grants Fast Track to Telix's pre-biopsy PSMA-PET program
The U.S. Food and Drug Administration has granted Fast Track designation to Telix Pharmaceuticals’ BiPASS program, which is evaluating gallium-68 (68Ga) PSMA-PET combined with MRI before prostate biopsy.
The phase 3 Biopsy of the Prostate Avoidance Stratification Study (BiPASS) is designed to determine whether adding prostate-specific membrane antigen PET to MRI can improve the detection of clinically significant prostate cancer, reduce unnecessary biopsies and better target biopsies when they are necessary. The study is utilizing Telix’s 68Ga-PSMA-PET imaging agents Illuccix and Gozellix in the initial prostate cancer diagnostic setting.
MRI is already used to identify suspicious prostate lesions and guide biopsies, while PSMA-PET can provide additional information about the biological activity and distribution of prostate cancer. The approach is intended to introduce molecular imaging earlier in the prostate cancer diagnostic pathway.
Telix said the program builds on findings from the PRIMARY and PRIMARY2 studies, which demonstrated that combining 68Ga-PSMA-PET with MRI could improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by nearly 50%.
More than 3 million prostate biopsies are performed globally each year, the majority of which (up to 75%) produce negative results. Telix says BiPASS is intended to help clinicians better determine which patients should undergo biopsy and, when appropriate, identify where sampling should be targeted. The strategy is not intended to eliminate biopsy when tissue diagnosis is clinically necessary. Instead, the goal is to use molecular and anatomic imaging together to improve patient selection and biopsy targeting before an invasive procedure is performed.
The FDA's Fast Track designation expedites the development and regulatory review of therapies designed to address serious conditions and unmet medical needs. Telix says the designation will allow for more frequent interaction with the FDA as it advances BiPASS toward a planned New Drug Application submission.
“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,” David N. Cade, MD, group chief medical officer at Telix, said in an announcement. “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.”
With phase 3 enrollment complete, Telix is now preparing for the next stage of regulatory review.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.