FDA Granted Fast Track Status to Prostate Cancer Program

The designation aims to speed up the review of a program using advanced imaging to reduce unnecessary biopsies.

Updated on Sept. 30, 2026 in Cancer

Isometric editorial illustration of medical imaging equipment including a PET scanner gantry and an MRI coil, rendered in flat muted colors. — The FDA has granted Fast Track status to the Telix Pharmaceuticals BiPASS program, which aims to improve prostate cancer diagnosis and reduce unnecessary biopsies. AI Illustration. Upload story photo >

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The FDA has granted Fast Track designation to the Telix Pharmaceuticals BiPASS program. This program combines gallium-68 PSMA-PET imaging and MRI to improve prostate cancer diagnosis.

Why it matters

The initiative aims to curb the high number of unnecessary invasive prostate biopsies performed globally each year. By improving diagnostic accuracy, the approach could significantly alter standard prostate care.

Clinical data indicates that combining PSMA-PET and MRI reduces unnecessary biopsies by nearly 50%. Currently, up to 75% of the 3 million prostate biopsies performed annually worldwide yield negative results.

The players

Telix Pharmaceuticals

This is a biopharmaceutical company headquartered in Australia that develops diagnostic and therapeutic products for cancer.

FDA

The Food and Drug Administration is the United States federal agency responsible for regulating medical products and public health.

The details

BiPASS integrates gallium-68 PSMA-PET scans with MRI to provide clearer guidance before physicians order invasive procedures. The FDA Fast Track status provides Telix Pharmaceuticals with more frequent regulator engagement to potentially accelerate the drug application review.

September 2026: The FDA granted Fast Track designation to the program.
Past 12 months: The Telix Pharmaceuticals share price increased 11%.

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The Big Picture

The BiPASS program follows the established pathway of the FDA Fast Track designation to expedite regulatory review for serious medical conditions.

Patients may eventually see a shift toward less invasive diagnostic procedures that rely on advanced imaging rather than traditional biopsies. This change could reduce the frequency of negative, uncomfortable biopsy outcomes for millions of men.

The takeaway

This development highlights a growing trend of utilizing molecular imaging to refine diagnostic accuracy in oncology. Improved pre-biopsy screening has the potential to spare patients from unnecessary physical discomfort and medical costs.