What are the next steps for PSMA-PET imaging in prostate cancer?

The PDUFA goal date for TLX007-CDx is March 24, 2025.

"We're excited that the FDA approval of this radiotracer gives us yet more tools at our disposal to diagnose prostate cancer in all its forms, from early to late in the disease process," says David M. Schuster, MD, FACR.

"To me, the most compelling outcome is really the quality-of-life outcomes. General quality of life as well as emotional quality of life improved in the intervention group significantly," says Jill M. Hamilton Reeves, PhD, RD, CSO.

On this podcast, Bristol Whiles, MD, discusses her urology residency experience at the Kansas University School of Medicine Department of Urology.

The BLA submission is supported by findings from the phase 3 ZIRCON trial, which demonstrated high specificity and sensitivity of TLX250-CDx for PET/CT imaging of ccRCC.

Patients with high-risk disease were shown to have a significantly higher mean value of SUVmax compared with patients with low-risk disease (23.5 ± 13.2 vs 10.6 ± 5.4; P < 0.05).