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# Blue Earth PET Imaging Drug Approved
- URL: https://www.fdaweb.com/blue-earth-pet-imaging-drug-approved/
- Published: 2023-05-30T12:00:00.000Z
- Updated: 2026-09-14T18:35:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154569

FDA has approved Blue Earth Diagnostics’ Posluma (flotufolastat F 18) injection, a prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent. The company is seeking an indication for PET imaging of 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.

Approval was based on data from two Blue Earth Diagnostics-sponsored Phase 3 trials (LIGHTHOUSE and SPOTLIGHT) that “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,” according to the company. The adverse reactions reported in clinical studies were diarrhea, blood pressure increase and injection site pain.