NCCN Adds Flotufolastat F 18 Injection to Clinical Practice Guidelines for Prostate Cancer

Eugene J. Teoh, MBBS, MRCP, FRCR, PhD

The National Comprehensive Cancer Network (NCCN) has added flotufolastat F 18 injection (Posluma; formerly ¹⁸F-rhPSMA-7.3) to its Clinical Practice Guidelines in Oncology 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, or in those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.¹

“The NCCN Guidelines are widely used by clinicians and health-care providers as a benchmark to assess clinical utility,” Eugene J. Teoh, MBBS, MRCP, FRCR, PhD, chief medical officer of Blue Earth Diagnostics, stated in a news release. “[Flotufolastat F 18] was developed to assist physicians in the detection and localization of prostate cancer. This update recognizes the important ability of PSMA-PET imaging procedures to detect and localize newly diagnosed and biochemically recurrent prostate cancer, which are essential to making appropriate patient management decisions.”

Flotufolastat F 18 is an optimized, targeted radiohybrid diagnostic imaging agent meant to help identify the location and extent of prostate cancer to guide the treatment of patients. The agent is based on a novel radiohybrid technology and is labeled with the radioisotope fluorine-18 (¹⁸F) to allow for PET imaging of the prostate and other areas of the body where prostate cancer could spread.

In May 2023, the FDA approved flotufolastat F 18 injection for PET of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are eligible for initial definitive therapy or with suspected recurrence based on elevated serum PSA level.²

The approval was supported by data from the phase 3 LIGHTHOUSE (NCT04186819) and SPOTLIGHT (NCT04186845) trials. Findings from LIGHTHOUSE demonstrated that the imaging agent had high specificity for identifying pelvic lymph nodes compared with histopathology standard of truth in patients with PSMA-positive lesions before undergoing radical prostatectomy. Data from SPOTLIGHT showed that that the agent had high detection rates via positive PET scans, even in those with low PSA levels.

SPOTLIGHT was a multicenter, single-arm trial that evaluated the diagnostic performance and safety of flotufolastat F 18 as a PET imaging agent in patients with suspected recurrence of prostate cancer based on elevated PSA levels following prior treatment.³

Findings showed that in a subset of patients who received prior primary treatment and radiation for prostate cancer (n = 76), PET imaging with flotufolastat F 18 led to an overall patient-level detection rate of 99%, and across 3 blinded central readers, the detection rates ranged from 93% to 99%. Recurrence by region was 76% for the prostate, 25% for pelvic lymph nodes, and 43% for extra-pelvic recurrences.

Regarding safety, 4.1% of all patients given flotufolastat F 18 (n = 391) experienced at least 1 treatment-emergent adverse (AE) effect considered related to or potentially related to the imaging agent. The most common AEs consisted of hypertension (1.8%), diarrhea (1.0%), injection site reaction (0.5%), and headache (0.5%).

LIGHTHOUSE was a multicenter, single-arm trial that examined the use of the imaging agent in newly diagnosed patients with prostate cancer (n = 335). Data showed that in these patients, who had unfavorable intermediate– to very high–risk prostate cancer and were scheduled to undergo radical prostatectomy and pelvic lymph node dissection, the detection of M1 lesions ranged from 16% to 28% across 3 blinded independent readers.⁴ Notably, 10% to 15% of patients had verified M1 lesions.

“The addition of [flotufolastat F 18] to the highly respected NCCN Guidelines is a major milestone for Blue Earth Diagnostics,” David E. Gauden, PhD, chief executive officer of Blue Earth Diagnostics, said in a news release. “We believe it further validates the clinical utility of [flotufolastat F 18] in patients with newly diagnosed or recurrent prostate cancer and can help expand patient access. In conjunction with our continuing efforts to increase U.S. commercial supply, Blue Earth is committed to make our new product widely available for patients and their physicians.”

References

1. Blue Earth Diagnostics announces addition of Posluma (flotufolastat F 18) injection to NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for prostate cancer. News release. Blue Earth Diagnostics. July 25, 2023. Accessed July 26, 2023. https://4078578.fs1.hubspotusercontent-na1.net/hubfs/4078578/POSLUMA%20inclusion%20in%20NCCN%20guidelines%20Final%20for%20July%2025%202023.pdf
2. 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 July 26, 2023. https://4078578.fs1.hubspotusercontent-na1.net/hubfs/4078578/POSLUMA%20approval%20press%20release%20FINAL%20for%20May%2030%202023.pdf
3. Blue Earth Diagnostics announces additional results from phase 3 SPOTLIGHT trial of investigational PET imaging agent 18F-rhPSMA-7.3 in biochemical recurrence of prostate cancer. News release. Blue Earth Diagnostics. April 29, 2023. Accessed July 26, 2023. https://4078578.fs1.hubspotusercontent-na1.net/hubfs/4078578/AUA%202023%20SPOTLIGHT%20subgroup%20results%20Final%20for%20April%2029%202023-2.pdf
4. 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 July 26, 2023. https://4078578.fs1.hubspotusercontent-na1.net/hubfs/4078578/Additional%20LIGHTHOUSE%20results%20for%20ASCO%20GU%202023%20February%2016%202023.pdf