The FDA has approved the flotufolastat F 18 injection for positron emission tomography of prostate-specific membrane antigen–positive lesions in patients with prostate cancer.
The FDA has granted approval to the flotufolastat F 18 injection (Posluma; formerly 18F-rhPSMA-7.3) for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)–positive lesions in patients with prostate cancer with suspected metastasis who are eligible for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level.1
“With the FDA approval of [Flotufolastat f 18 injection], we realize our goal of providing an important product that will be widely available across the United States to help inform the management and treatment of patients across the prostate cancer care continuum,” David E. Gauden, DPhil, chief executive officer of Blue Earth Diagnostics,” said, in a press release.
In the phase 3 LIGHTHOUSE (NCT04186819) and SPOTLIGHT (NCT04186845) trials, the flotufolastat F 18 injection demonstrated ability to detect distant metastatic lesions,2 and showed a clinically meaningful correct detection rate, increasing upstaging of disease in recurrent prostate cancer.3 The correct detection rate was between 45% and 47%, which defines the percentage of patients scanned with at least 1 true positive PET finding compared with the Standard of Truth of histopathology or confirmatory conventional imaging.3
“This event marks a major milestone in the expansion of Blue Earth Diagnostics’ robust prostate cancer portfolio. [Flotufolastat f 18 injection] was developed to assist physicians in the detection and localization of prostate cancer. It represents a new class of purposely engineered, high-affinity PSMA-targeted radiopharmaceuticals based on novel radiohybrid technology, which may offer diagnostic imaging and therapeutic potential. All of us at Blue Earth Diagnostics want to express our sincere gratitude to the many patients, physicians, clinical trial sites and collaborators who have worked closely with us to progress [Flotufolastat f 18 injection],” Gauden stated.