Flotufolastat F 18: Diagnostic First Approval

Area of Science:

• Nuclear Medicine
• Radiopharmaceutical Development
• Oncology Imaging

Background:

• Prostate cancer diagnosis relies on accurate imaging to detect metastasis.
• Current imaging agents face limitations in sensitivity and specificity.
• Prostate-specific membrane antigen (PSMA) is a key biomarker for prostate cancer.

Purpose of the Study:

• To summarize the development milestones of flotufolastat F 18.
• To highlight the regulatory approval of flotufolastat F 18 in the USA.
• To introduce flotufolastat F 18 as a new PSMA-targeted imaging agent.

Main Methods:

• Development of an 18F-labelled radiohybrid agent.
• Targeting of prostate-specific membrane antigen (PSMA).
• Clinical application in positron emission tomography (PET).

Main Results:

• Flotufolastat F 18 (POSLUMA®) received US FDA approval in May 2023.
• Approved for PET imaging of PSMA-positive lesions in prostate cancer.
• Indicated for men with suspected metastasis or recurrence.

Conclusions:

• Flotufolastat F 18 represents a significant advancement in prostate cancer imaging.
• The approval facilitates improved diagnostic capabilities for metastatic and recurrent prostate cancer.
• This radiohybrid agent enhances the detection of PSMA-positive lesions.