FDA Approves Imaging Agent With Radiohybrid Technology to Identify Location, Extent of Prostate Cancer


The radiohybrid imaging agent allowed positron emission tomography to identify prostate cancer with an 83% detection rate.

The FDA has approved flotufolastat F 18 (Posluma; Blue Earth Diagnostics) injection, a positron emission tomography (PET) imaging agent for prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer, according to a Blue Earth Diagnostics press release. This is the first and only FDA-approved and PSMA-targeted agent to include radiohybrid (rh) technology.

Image Credit: Adobe Stock - Calin

Image Credit: Adobe Stock - Calin

“[Flotufolastat F 18] 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, in a recent press release. “It represents a new class of purposely engineered, high-affinity PSMA-targeted radiopharmaceuticals based on novel [rh] technology, which may offer diagnostic imaging and therapeutic potential.”

The indication is suitable for men with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

A significant population of patients with prostate cancer have regional pelvic lymph node metastases that increase the risk of recurrence and impact overall survival (OS), said study investigator Brian F. Chapin, MD, associate professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, in the press release.

“Effective staging in newly diagnosed prostate cancer—determining its presence and helping determine whether it may have metastasized—is critical in establishing optimal clinical management strategies, because up to 25% of patients with primary prostate cancer may have detectable regional pelvic lymph node metastases, which are correlated with a risk for recurrence and associated overall survival,” Chapin said in the release. “Conventional imaging techniques such as CT and MRI 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 (PLND) prior to [flotufolastat F 18]. The study showed that [flotufolastat F 18] provided clinically valuable information prior to surgery that would likely result in management changes for these patients.”

The approval was based on a pair of phase 3 trials that established the imaging agent’s safety and diagnostic performance for detecting prostate cancer. The LIGHTHOUSE study evaluated flotufolastat F 18 injection for patients with unfavorable intermediate to very high risk for pelvic lymph nodes prior to surgery, Chapin explained. The results showed that the imaging agent had a higher specificity than histopathology standard of truth.

The second trial, SPOTLIGHT, evaluated diagnostic performance. It showed that flotufolastat F 18 injection, despite low PSA levels, had high detection rates, defined as the percentage of positive PET scans. The imaging agent allowed the PET to locate cancer at an 83% detection rate, according to study investigator David M. Schuster, MD, FACR, Emory University School of Medicine, professor at Emory University School of Medicine and researcher at the Winship Cancer Institute at Emory University.

“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,” Schuster said in the release. “The ability to determine the extent and location of recurrent disease is necessary to inform physicians and their patients for appropriate clinical management.”

Flotufolastat F 18 injection is a molecule that binds to PSMA-expressing cells like prostate cells. It is labeled with radioisotope fluorine-18 (18F) and leverages the high image quality of 8F-labeled PSMA PET imaging to detect cancer in the prostate and that has spread to other parts of the body. The injection is part of a new class of high-affinity PSMA-target PET radiopharmaceuticals that can effectively detect the location and extent of prostate cancer to guide patient management.

The most common adverse events associated with flotufolastat F 18 injection include diarrhea, increased blood pressure, and injection site pain. Flotufolastat F 18 will be commercially available in June 2023 and nationally available throughout the coming months.

“With the FDA approval of [flotufolastat F 18], we realize our goal of providing an important product that will be widely available across the United States to help inform the management and treatment of patients across the prostate cancer care continuum,” Gauden said in the press release.


Blue Earth Diagnostics. U.S. FDA Approves Blue Earth Diagnostics’ POSLUMA® (Flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer. News Release. May 30, 2023. Accessed May 30, 2023. https://www.businesswire.com/news/home/20230530005180/en/U.S.-FDA-Approves-Blue-Earth-Diagnostics%E2%80%99-POSLUMA%C2%AE-Flotufolastat-F-18-Injection-First-Radiohybrid-PSMA-targeted-PET-Imaging-Agent-for-Prostate-Cancer

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