Blue Earth PET Imaging Drug Approved

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.