Posted: Wednesday, May 31, 2023
On May 30, Blue Earth Diagnostics announced U.S. Food and Drug Administration (FDA) approval of its radiohybrid (rh) prostate-specific membrane antigen (PSMA)-targeted PET imaging agent—flotufolastat F 18 (Posluma) injection (formerly referred to as 18F-rhPSMA-7.3). This agent is indicated for detecting PSMA-positive lesions in people with prostate cancer who have suspected metastasis or recurrence based on elevated serum prostate-specific antigen (PSA) levels and are candidates for initial definitive therapy. It is the first FDA-approved, PSMA-targeted imaging agent developed with proprietary radiohybrid technology.
This optimized PSMA-targeted molecule 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 (18F) to enable PET imaging of the prostate and other areas of the body where prostate cancer may have spread.
The approval of flotufolastat F 18 is based on data from two phase III trials: LIGHTHOUSE and SPOTLIGHT. Results from the LIGHTHOUSE study demonstrated high specificity for the detection of pelvic lymph nodes as compared with the histopathology standard of truth in patients with PSMA-positive lesions prior to radical prostatectomy. The SPOTLIGHT study evaluated flotufolastat F 18 in people with suspected prostate cancer recurrence based on elevated PSA levels after prior therapy. Results demonstrated high detection rates, even at low PSA levels.
In clinical trials, the safety of flotufolastat F 18 was evaluated in 747 patients with initial or recurrent prostate cancer. The adverse reactions reported in at least 0.4% of patients in clinical studies were diarrhea, blood pressure increase, and injection-site pain.