FDA Approves Posluma (flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer
Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced U.S. Food and Drug Administration (FDA) approval for its optimized, high-affinity radiohybrid (rh) Prostate-Specific Membrane Antigen (PSMA)-targeted PET imaging agent, Posluma® (flotufolastat F 18) injection (formerly referred to as F-rhPSMA-7.3). Posluma is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) 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 (PSA) level.
It is the first and only FDA-approved, PSMA-targeted imaging agent developed with proprietary radiohybrid (rh) technology. Posluma will be commercially available in early June 2023, through certain radiopharmacies in the national radiopharmacy network of Blue Earth Diagnostics’ commercial U.S. manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company. It will become increasingly available nationally in the coming months.
