FDA Approves New PSMA PET Agent POSLUMA for Prostate Cancer Imaging

The Food and Drug Administration (FDA) has approved POSLUMA® (flotufolastat F18), the prostate-specific membrane antigen (PSMA)-targeted formerly known as ¹⁸F-rhPSMA-7.3, for multiple indications in positron emission tomography (PET) imaging of men with prostate cancer.

POSLUMA (Blue Earth Diagnostics) is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer and suspected metastasis who are candidates for initial definitive treatment. The first FDA-approved PSMA PET agent with proprietary radiohybrid technology, POSLUMA is also approved for men with suspected prostate cancer recurrence based on an elevated serum prostate-specific antigen (PSA) level.

Citing recent literature, David M. Schuster, M.D., F.A.C.R., said POSLUMA represents a significant advance for a disease that has high rates of recurrence.

“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,” explained Dr. Schuster, a professor of radiology and imaging sciences at the Emory University School of Medicine. “ … 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.”

In a recent interview with Diagnostic Imaging from the American Urological Association (AUA) Annual Meeting, Brian Helfand, M.D., discussed a subgroup analysis from the SPOTLIGHT study of 389 patients treated with primary radiation therapy for prostate cancer. In addition to diagnosing prostate cancer recurrence in 76 patients with a median PSA baseline of 4.4 ng/mL, the use of POSLUMA detected recurrence in distant extra-pelvic sites in 43 percent of patients, according to Dr. Helfand, chief of the Division of Urology for the NorthShore University HealthSystem, and a clinical professor at the University of Chicago.

Blue Earth Diagnostics noted that POSLUMA will be initially available in early June 2023 through certain radiopharmacies in the radiopharmacy network of PETNET Solutions/Siemens Healthineers, and have more widespread availability in the United States in the coming months.

(Editor’s note: For related content, see “Can an Emerging PSMA/PET Agent Improve Detection of Prostate Cancer Recurrence in Patients with Low PSAs?” and “Could a New PSMA PET Agent Improve Detection of Distant Metastatic Lesions in Patients with Prostate Cancer?”)