Is Posluma approved by the FDA?

Yes, Posluma (flotufolastat F 18) is FDA approved. The US Food and Drug Administration (FDA) approved Posluma injection on May 25, 2023. The approval was based on the results of two phase 3 trials, LIGHTHOUSE (NCT04186819) and SPOTLIGHT (NCT04186845).

What is Posluma?

Posluma, with the generic name flotufolastat F 18, is an imaging agent used in PET (positron emission tomography) scans to detect and locate prostate cancer. Posluma contains an imaging agent (18F radioscope) designed to specifically bind to Prostate-Specific Membrane Antigen (PSMA) on prostate cancer cells, allowing physicians to accurately identify and locate prostate cancer cells within the body. It is classified as a Radiohybrid PSMA-targeted PET Imaging Agent.

Uses of Posluma

Posluma is FDA-approved as a radioactive diagnostic agent during PET scans for PSMA-positive lesions in men with prostate cancer who have:

• Suspected metastasis and are candidates for initial definitive therapy.
• Suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Administration of Posluma

• Hydration: Patients should drink sufficient water to ensure they are well-hydrated before their PET study.
• Bladder Emptying: Patients should empty their bladder immediately before imaging.
• Injection: Posluma is administered as an intravenous injection approximately 60 minutes before the PET scan. The PET scan typically takes around 20 minutes, depending on the number of bed positions and time per bed position.
• Post-Administration: It is important to drink and urinate frequently during the first hours after receiving the injection to reduce radiation exposure.

Dosing Information

• Recommended Dose: 296 MBq (8 mCi) as an intravenous bolus injection.
• Volume Calculation: The necessary volume to administer should be calculated based on calibration time and required dose. The recommended maximum volume of undiluted Posluma is 5 mL.
• Dilution: Posluma may be diluted with 0.9% Sodium Chloride Injection, USP.
• Assay: The dose should be assayed in a dose calibrator before administration.
• Post-Injection: An intravenous flush of sterile 0.9% Sodium Chloride Injection should be administered to ensure full dose delivery.

Side Effects

Common side effects of Posluma may include:

• Diarrhea
• Blood pressure increase
• Injection site pain

Warnings and Precautions

• Radiation Risks: Posluma contributes to a patient’s long-term cumulative radiation exposure.
• Risk of Image Misinterpretation: The interpretation of Posluma PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Multidisciplinary consultation and histopathological confirmation are advised when clinical decision-making hinges on uptake only in these regions or on uptake interpreted as borderline.

Drug Interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can alter the absorption of Posluma into prostate cancer. The effect of these therapies on the performance of Posluma PET has not been established.

Pregnancy and Breastfeeding

Posluma is not indicated for use in females. Radioactive drugs have the potential to cause fetal harm depending on the fetal stage of development and the size of the radiation dose. There is no data on the presence of this medicine in human milk, the effect on the breastfed infant, or the effect on milk production.

Storage

• Temperature: Store at 20°C to 25°C (68°F to 77°F).
• Container: Store in the original container with radiation shielding.
• Expiration: The expiration date and time are provided on the container label. Use within 10 hours from the end of synthesis.
• Disposal: Unused solution should be disposed of in compliance with applicable regulations.

Conclusion

Posluma (flotufolastat F 18) is an FDA-approved diagnostic radiopharmaceutical used for PET imaging to detect and locate prostate cancer. Approved based on robust clinical trials, it offers a targeted approach to identifying PSMA-positive lesions, aiding in accurate diagnosis and treatment planning for prostate cancer patients. As with any radiopharmaceutical, appropriate precautions and administration guidelines must be followed to ensure patient safety and efficacy of the diagnostic process.

How to obtain the latest development progress of all drugs?

In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!