Blue Earth Diagnostics Announces FDA Acceptance of New Drug Application for 18F-rhPSMA-7.3, a Radiohybrid Prostate-Specific Membrane Antigen-Targeted PET Imaging Agent for Prostate Cancer
The submission is for the use of 18F-rhPSMA-7.3 PET for diagnostic imaging of prostate cancer.
- The submission is for the use of 18F-rhPSMA-7.3 PET for diagnostic imaging of prostate cancer.
- Subject to FDA approval, we believe that 18F-rhPSMA-7.3 PET imaging may be clinically useful in the management of men affected by prostate cancer across the care continuum.
- Blue Earth Diagnostics Phase 3 LIGHTHOUSE trial assessed the safety and diagnostic performance of 18F-rhPSMA-7.3 PET in men with newly diagnosed prostate cancer in 356 patients.
- Prostate cancer is the second most frequently diagnosed cancer in men and the fifth leading cause of death worldwide.