Flotufolastat F 18

(Posluma®)

Flotufolastat F 18

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Drug updated on 4/16/2024

Dosage FormInjection (intravenous; 296 MBq/mL to 5,846 MBq/mL [8 mCi/mL to 158 mCi/mL] as flotufolastat F 18 gallium in approximately 25 mL at end of synthesis in a multiple-dose vial)
Drug ClassRadioactive diagnostic agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy.
  • Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Summary
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  • Flotufolastat F 18 (Posluma) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen-positive lesions in men with prostate cancer who are suspected of having metastasis and are candidates for initial definitive therapy. It is also used in cases where there is a suspicion of recurrence based on elevated serum prostate-specific antigen levels.
  • Two studies focusing on the diagnostic performance and safety profile of Posluma in patients with newly diagnosed or recurrent prostate cancer susceptible to PET scan analysis were analyzed.
  • In terms of effectiveness, Posluma showed high specificity but limited sensitivity in detecting pelvic lymph node metastases among newly diagnosed patients. However, it demonstrated higher sensitivity among those with high-/very-high-risk compared to unfavorable intermediate-risk groups.
  • For recurrent prostate cancer cases, Posluma exhibited a clinically meaningful verified detection rate exceeding pre-specified statistical thresholds despite failing to meet the combined region-level positive predictive value co-primary endpoint.
  • The safety data from the studies indicate that no significant concerns were identified, thus suggesting that flotufolastat F 18 is well tolerated by patients either newly diagnosed or having recurrent instances of the disease.
  • Subgroup considerations imply that this drug could be particularly useful for diagnosis and management within specific patient subgroups, such as those at higher risk or presenting with recurring disease due to its varying sensitivity based on disease status and risk category.

Product Monograph / Prescribing Information

Document TitleYearSource
Posluma (flotufolastat F18) Prescribing Information. 2023Blue Earth Diagnostics Ltd., Oxford, UK

Randomized Controlled Trials

Clinical Practice Guidelines