FDA Approves Posluma, First Radiohybrid PSMA-Targeted PET Imaging Agent for Prostate Cancer
• The FDA has approved flotufolastat F 18 injection (Posluma) for PET imaging of PSMA-positive lesions in prostate cancer patients, aiding in metastasis detection and recurrence assessment.
• Posluma, developed by Blue Earth Diagnostics, utilizes radiohybrid technology to target PSMA, offering high specificity and detection rates, even at low PSA levels, as shown in LIGHTHOUSE and SPOTLIGHT trials.
• Clinical trials demonstrated Posluma's ability to accurately identify pelvic lymph nodes and distant metastatic lesions, with a high overall patient-level detection rate of 99% in recurrence cases.
• The agent, expected to be commercially available in June 2023, offers a new tool for physicians in managing prostate cancer by improving the detection and localization of the disease.
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