![]() ![]() “This event marks a major milestone in the expansion of Blue Earth Diagnostics’ robust prostate cancer portfolio. Gauden, DPhil., chief executive officer of Blue Earth Diagnostics, stated in a press release. “With the FDA approval of Posluma, we realize our goal of providing an important product that will be widely available across the United States to help inform the management and treatment of patients across the prostate cancer care continuum,” David E. It will continue to become available on a national scale in the coming months. The imaging agent is slated to be commercially available in early June 2023. Data from SPOTLIGHT indicated that the agent had high detection rates, in the form of positive PET scans, even in those with low PSA levels. The regulatory decision is supported by findings from two phase 3 trials: LIGHTHOUSE (NCT04186819) and SPOTLIGHT (NCT04186845).įindings from LIGHTHOUSE indicated that the imaging agent had high specificity when it came to identifying pelvic lymph nodes vs histopathology standard of truth in patients who had PSMA-positive lesions before undergoing radical prostatectomy. The radioisotope utilizes the high quality of 18F-labeled PSMA PET imaging to effectively identify disease and allow for broad access for patients. It is labeled with the radioisotope fluorine-18 (18F) to allow for PET imaging of the prostate and other areas of the body where prostate cancer could spread. The product is an optimized PSMA-targeted molecule that binds to and is internalized by PSMA-expressing cells, including prostate cancer cells, which are known to have PSMA overexpression. The FDA has approved flotufolastat F 18 injection (Posluma formerly 18F-rhPSMA-7.3) for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer with suspected metastasis who are eligible for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level. ![]()
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