The US Food and Drug Administration has approved Posluma (flotufolastat F 18), a PET imaging agent, for use in detecting prostate-specific membrane antigen (PSMA)-positive lesions in patients with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy or who have suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels.
Posluma consists of a radiohybrid PSMA-targeted receptor ligand that binds to and is internalized by prostate cancer cells. The product assists clinicians in detecting and localizing prostate cancer as fluorine-18, a ß+ emitting radionuclide that can be detected using PET.
The approval of Posluma was based on data from a pair of phase 3 trials — the LIGHTHOUSE study (ClinicalTrials.gov Identifier: NCT04186819) and the SPOTLIGHT study (ClinicalTrials.gov Identifier: NCT04186845).
In the LIGHTHOUSE study, Posluma demonstrated high specificity for the detection of pelvic lymph nodes in men with PSMA-positive lesions prior to radical prostatectomy.
In the SPOTLIGHT study, Posluma enabled high detection rates in men with suspected prostate cancer recurrence even at low PSA levels.
The most common adverse reactions reported with Posluma were diarrhea, increased blood pressure, and injection site pain.
Posluma is expected to be commercially available in early June.
US FDA approves Blue Earth Diagnostics’ Posluma® (flotufolastat F 18) injection, first radiohybrid PSMA-targeted PET imaging agent for prostate cancer. News release. May 30, 2023. https://www.businesswire.com/news/home/20230530005180/en/U.S.-FDA-Approves-Blue-Earth-Diagnostics%E2%80%99-POSLUMA%C2%AE-Flotufolastat-F-18-Injection-First-Radiohybrid-PSMA-targeted-PET-Imaging-Agent-for-Prostate-Cancer
Posluma. Package insert. Blue Earth Diagnostics; 2023. Accessed May 30, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf
This article originally appeared on MPR