The US Food and Drug Administration (FDA) has approved Blue Earth Diagnostics’ prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent, POSLUMA (flotufolastat F 18). The high-affinity radiohybrid is the first and only FDA-approved agent of its kind. It will be widely accessible for patients across the United States.
Formerly known as 18F-rhPSMA-7.3, POSLUMA is an optimized diagnostic imaging agent for the PET detection of PSMA-positive lesions in patients with prostate cancer with suspected metastasis or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level or who are candidates for initial definite therapy.
The agent is labeled with fluorine-18 (18F) to enable PET imaging of the prostate to identify the location and extent of cancer.
“POSLUMA was developed to assist physicians in the detection and localization of prostate cancer,” said David E. Gauden, DPhil, chief executive officer of Blue Earth Diagnostics. “It represents a new class of purposely engineered, high-affinity PSMA-targeted radiopharmaceuticals based on novel radiohybrid technology, which may offer diagnostic imaging and therapeutic potential.”
The FDA’s approval of POSLUMA is based on the phase 3 LIGHTHOUSE and SPOTLIGHT trials that were sponsored by Blue Earth Diagnostics. The LIGHTHOUSE study results showed high specificity for the detection of pelvic lymph nodes, while the SPOTLIGHT study demonstrated an overall detection rate of 83% in patients even at low PSA levels.
According to Brian F. Chapin, MD, an associate professor in the Department of Urology at The University of Texas MD Anderson Cancer Center and coordinating investigator of the phase 3 LIGHTHOUSE study, “conventional imaging techniques such as [computed tomography] and [magnetic resonance imaging] are limited in the information they may provide. The LIGHTHOUSE study looked at unfavorable intermediate-, high-, and very high-risk patients who were scheduled for radical prostatectomy plus pelvic lymph node dissection prior to POSLUMA PET. The study showed that POSLUMA PET provided clinically valuable information prior to surgery that would likely result in management changes for these patients.”
POSLUMA will be commercially available in early June 2023 and will be made increasingly available nationally in the coming months.