NCCN adds flotufolastat F 18 to prostate cancer guidelines

The National Comprehensive Cancer Network (NCCN) has added flotufolastat F 18 (formerly ¹⁸F-rhPSMA-7.3; trade name, Posluma) to its clinical practice guidelines for prostate cancer (version 2.2023), according to Blue Earth Diagnostics, the developer of the PSMA-PET imaging agent.¹

The FDA approved flotufolastat F 18 based on findings from the phase 3 SPOTLIGHT and LIGHTHOUSE trials, and much of the same data was considered by the NCCN panel that added the imaging agent to the prostate cancer guidelines.

Flotufolastat F 18 is approved by the FDA for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level.² It is now included in the NCCN guideline recommendations for all the same categories as the other PSMA-PET imaging agents approved by the FDA.

“The NCCN Guidelines are widely used by clinicians and healthcare providers as a benchmark to assess clinical utility,” Eugene J. Teoh, MBBS, MRCP, FRCR, DPhil, chief medical officer of Blue Earth Diagnostics, stated in a press release.¹ “Posluma 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. ”

FDA approval of flotufolastat F 18

SPOTLIGHT

The multicenter, single-arm, phase 3 SPOTLIGHT study (NCT04186845) examined the safety and diagnostic performance of flotufolastat F 18 injection as a PET imaging product in men who had suspected prostate cancer recurrence based on elevated PSA after previous therapy.³

The efficacy population included 389 patients with an evaluable PET scan. The mean patient age was 68 years (range, 43-86) and the median baseline PSA serum level was 1.1 ng/mL.³

The flotufolastat F 18 scans were evaluated independently by 3 blinded central readers. Across all 3 readers, 46% to 60% of the regions determined to be positive for prostate cancer recurrence on the flotufolastat F 18 scan were also determined to be positive based on the reference standard. According to the product labeling, the reference standard consisted of “other imaging evaluated by a separate consensus panel or histopathology.”³

LIGHTHOUSE

The prospective, multicenter, single-arm, phase 3 LIGHTHOUSE study (NCT04186819) examined flotufolastat F 18 injection in patients with newly diagnosed prostate cancer. Patients enrolled in the trial had unfavorable intermediate-risk (about one-third) or high-/very high-risk (about two-thirds) prostate cancer.³

In this study, there were 296 patients (mean age, 65 years; range, 46-82) who received standard prostatectomy and pelvic lymph node dissection. Of these patients, histopathology showed that around 24% had pelvic lymph node metastases.³

Flotufolastat F 18 scans were evaluated independently by 3 blinded readers. The performance of flotufolastat F 18 was compared with “histopathology after matching by hemipelvis,” according to the product labeling.³

The results showed that flotufolastat F 18 had a low sensitivity for predicting positive lymph nodes. The sensitivity among the 3 readers ranged from 23% to 30%. However, flotufolastat F 18 rated high for specificity with a range of 93% to 97% among the readers.³

Safety

The safety of flotufolastat F 18 was evaluated in a population of 747 patients with initial or recurrent prostate cancer enrolled across clinical trials. The most common (≥0.4% incidence) adverse reactions in the studies were diarrhea, blood pressure increase, and injection site pain.³

“The addition of Posluma to the highly respected NCCN Guidelines is a major milestone for Blue Earth Diagnostics,” David E. Gauden, D. Phil, chief executive officer of the company, stated in a press release.¹ “We believe it further validates the clinical utility of Posluma 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. Accessed July 26, 2023. https://www.businesswire.com/news/home/20230725319846/en

2. U.S. FDA Approves Blue Earth Diagnostics’ POSLUMA® (Flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer. Accessed May 30, 2023. https://tinyurl.com/mpbdk5br

3. Highlights of prescribing information. POSLUMA (flotufolastat F 18) injection, for intravenous use. Initial U.S. Approval: 2023. https://www.posluma.com/prescribing-information.pdf