Drugdocs | Flotufolastat F 18

Drug updated on 4/16/2024

Dosage Form	Injection (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 Class	Radioactive 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 Title	Year	Source
Posluma (flotufolastat F18) Prescribing Information.	2023	Blue Earth Diagnostics Ltd., Oxford, UK

Randomized Controlled Trials

Document Title	Sex Distribution	Year	Source
Diagnostic performance and safety of positron emission tomography with 18F-rhPSMA-7.3 in patients with newly diagnosed unfavourable intermediate- to very-high-risk prostate cancer: Results from a phase 3, prospective, multicentre study (LIGHTHOUSE).	352Subjects F: 0% M: 100%	2023	European Urology
Diagnostic performance and safety of 18F-rhPSMA-7.3 positron emission tomography in men with suspected prostate cancer recurrence: Results from a phase 3, prospective, multicenter study (SPOTLIGHT).	389Subjects F: 0% M: 100%	2023	The Journal of Urology

Document Title

Diagnostic performance and safety of positron emission tomography with 18F-rhPSMA-7.3 in patients with newly diagnosed unfavourable intermediate- to very-high-risk prostate cancer: Results from a phase 3, prospective, multicentre study (LIGHTHOUSE).

Sex Distribution:

F:0%

M:100%

352Subjects

Year:

2023

Source:European Urology

Document Title

Diagnostic performance and safety of 18F-rhPSMA-7.3 positron emission tomography in men with suspected prostate cancer recurrence: Results from a phase 3, prospective, multicenter study (SPOTLIGHT).