31 May 2023 - - PET radiopharmaceuticals developer Blue Earth Diagnostics, a Bracco company, has received US Food and Drug Administration approval for its optimized, high-affinity radiohybrid Prostate-Specific Membrane Antigen -targeted PET imaging agent, POSLUMA (flotufolastat F 18) injection (formerly referred to as 18F-rhPSMA-7.3), the company said.

POSLUMA is indicated for positron emission tomography of prostate-specific membrane antigen positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level.

It is the first and only FDA-approved, PSMA-targeted imaging agent developed with proprietary radiohybrid technology.

POSLUMA will be commercially available in early June 2023, through certain radiopharmacies in the national radiopharmacy network of Blue Earth Diagnostics' commercial US manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers company. It will become increasingly available nationally in coming months.

POSLUMA is an optimized PSMA-targeted molecule that binds to and is internalized by cells that express PSMA, including prostate cancer cells, which usually overexpress PSMA. 

It is labeled with the radioisotope fluorine-18 to enable PET imaging of the prostate and other areas of the body where prostate cancer may have spread.

The 18F radioisotope leverages the high image quality of 18F-labeled PSMA PET imaging to facilitate effective detection of disease and enables broad, readily available geographic access for patients.

The approval of POSLUMA is based on data from two Blue Earth Diagnostics-sponsored Phase 3 trials (LIGHTHOUSE and SPOTLIGHT), designed to establish the safety and diagnostic performance of POSLUMA across the continuum of prostate cancer care.

Results from the LIGHTHOUSE study demonstrated high specificity for the detection of pelvic lymph nodes as compared to histopathology standard of truth in men with PSMA-positive lesions prior to radical prostatectomy.

The SPOTLIGHT study evaluated POSLUMA in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Results demonstrated high detection rates (% positive PET scans) even at low PSA levels.

In clinical trials, the safety of POSLUMA was evaluated in 747 patients with initial or recurrent prostate cancer. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.

POSLUMA (flotufolastat F 18) injection (formerly referred to as 18F-rhPSMA-7.3) is an optimized, targeted radiohybrid diagnostic imaging agent indicated for positron emission tomography of prostate-specific membrane antigen positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial therapy or with suspected recurrence based on elevated serum prostate-specific antigen level.

Precision PET imaging with POSLUMA can help identify the location and extent of prostate cancer, providing clinically valuable information to guide patient management.

POSLUMA represents a new class of high-affinity PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid technology and is labeled with the radioisotope 18F to provide readily available patient access and leverage the high image quality of 18F-labeled PSMA PET imaging to facilitate effective detection of disease.

POSLUMA was approved by the US Food and Drug Administration in May, 2023.

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and they may be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use providing the potential for creating a true theranostic technology.

Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany.

Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics.

Blue Earth Diagnostics received US Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product for use in prostate cancer in 2023.

rhPSMA compounds for potential therapeutic use are investigational and have not received regulatory approval.

POSLUMA (flotufolastat F 18) injection is indicated for positron emission tomography of prostate-specific membrane antigen positive lesions in men with prostate cancer.

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care.

Formed in 2014, the company's success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography radiopharmaceuticals.

Blue Earth Diagnostics' expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology.

Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy.

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider.

Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions.

In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics.

In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies.