The Food and Drug Administration (FDA) approved POSLUMA®, the first radiohybrid drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen-positive lesions in men with prostate cancer. Precision PET imaging with POSLUMA can identify primary and metastatic prostate cancer, providing valuable information to help doctors and patients determine a course of treatment.
The FDA approval was based on data from two phase 3 trials (LIGHTHOUSE and SPOTLIGHT), which established the safety and diagnostic performance of POSLUMA in 747 patients with initial or recurrent prostate cancer. Coordinating investigator for the SPOTLIGHT study was Winship researcher David M. Schuster, MD, FACR, professor of radiology and imaging sciences at Emory University School of Medicine.
"The highly variable nature of recurrent prostate cancer presents clinical challenges, and up to 40% of patients who undergo radical prostatectomy, and up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years," says Schuster. "The ability to determine the extent and location of recurrent disease is necessary to inform physicians and their patients for appropriate clinical management. The phase 3 SPOTLIGHT study investigated the diagnostic performance of POSLUMA PET imaging as a potential decision-making aid in assessing suspected biochemical recurrence of the disease and demonstrated that it offered precision diagnostic performance even at low PSA levels with an overall 83% detection rate."
POSLUMA was developed by Blue Earth Diagnostics. Read the full press release here.