Blue Earth Diagnostics’ Posluma (flotufolastat F 18) Receives the US FDA’s Approval for the Treatment of Prostate Cancer
Shots:
- The US FDA has approved Posluma, an optimized, rh PSMA-targeted PET imaging agent in men with prostate cancer with suspected metastasis. Posluma is expected to be commercially available in the US in early June 2023
- The approval was based on the 2 P-III trials (LIGHTHOUSE & SPOTLIGHT) evaluating the safety and diagnostic performance of Posluma. The (LIGHTHOUSE) study results showed high specificity for the detection of pelvic lymph nodes over histopathology standard of truth in men with PSMA+ lesions before radical prostatectomy
- The (SPOTLIGHT) study demonstrated 83% detection rates even at low PSA levels in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy
Ref: Businesswire | Image: Blue Earth
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