FDA Approves New Imaging Agent for Prostate Cancer

Data from the American Cancer Society suggests that approximately one in eight males will be diagnosed with prostate cancer. Effective screening for prostate cancers allows for better treatments and survival rates. Despite the benefits of early diagnosis, early stages of prostate cancer are often left undetected as patients are asymptomatic. The FDA approval of 18F-rhPSMA-7.3, an imaging agent created by Blue Earth Diagnostics to detect prostate cancer in PET scans, offers an additional tool for providers.

According to the press release, this agent is an investigational radio hybrid prostate-specific membrane antigen-targeted (PSMA) PET imaging agent. The company outlines that the agent has distinct domains. The first domain is the antigen-targeted receptor ligand. The agent attaches to prostate cancer cells. The prostate cancer cells internalize the ligand, at which point the 18F isotope allows the agent to appear in PET imaging scans.

This approval follows multiple prospective clinical trials. The first of the phase III studies, LIGHTHOUSE, analyzed the agent’s safety and diagnostic performance in over 350 patients. SPOTLIGHT, the other phase III clinical trial, used the agent in nearly 400 men with elevated PSA levels.

“This event marks a significant milestone in advancing our robust prostate cancer portfolio, and we are very pleased that the FDA has accepted our NDA submission for the use of 18F-rhPSMA-7.3PET imaging in prostate cancer patients,” said David E. Gauden, PhD, Chief Executive Officer of Blue Earth Diagnostics, in the press release.

“We look forward to working with the Agency throughout the review process, with the goal of having an approved product that is widely available and accessible across the United States. 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.”

Additional investigations must be conducted to compare this study with traditional diagnostic measures. However, the availability of this extra tool may improve the rate of prostate cancer diagnoses. Clinicians who suspect a patient of having or being at risk for prostate cancer may consider using this agent.