FDA Approves Injectable Flotufolastat F 18 for Prostate Cancer

• Flotufolastat f 18 injection (Posluma; formerly 18F-rhPSMA-7.3) is the first radiohybrid PSMA-targeted pet imaging agent to be approved in prostate cancer.

• Findings from 2 phase 3 clinical trials support the FDA approval.

• The agent will be commercially available in the United States in June 2023

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.

REFERENCES:

US FDA approves Blue Earth Diagnostics' Posluma (flotufolastat F 18 injection, first radiohybrid PSMA-targeted PET imaging agent for prostate cancer. News release. Blue Earth Diagnostics. May 30, 2023. Accessed May 30, 2023. https://tinyurl.com/355xaeu8

Fleming MT. Impact of 18F-rhPSMA-7.3 PET on upstaging of patients with prostate cancer recurrence: results from the prospective, phase 3, multicenter, SPOTLIGHT study. Presented at: 2022 AUA Annual Meeting; May 13-16, 2022; New Orleans, LA. Abstract PLLBA-02.

Blue Earth Diagnostics announces additional results from phase 3 LIGHTHOUSE trial of investigational PET imaging agent 18F-rhPSMA-7.3 in newly diagnosed prostate cancer. News release. Blue Earth Diagnostics. February 16, 2023. Accessed May 30, 2023. https://tinyurl.com/3dhxwb58