Flotufolastat F 18 Added to NCCN Clinical Practice Guidelines for Prostate Cancer

By Zachary Bessette - Last Updated: July 27, 2023

The National Comprehensive Cancer Network (NCCN) now includes flotufolastat F 18 (POSLUMA) in its clinical practice guidelines for prostate cancer (version 2.2023).

The injection is included in the NCCN guideline recommendations for all the same categories as other prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging agents approved by the US Food and Drug Administration (FDA).

Blue Earth Diagnostics, the developer of flotufolastat F 18, announced this addition in late July. The injection was approved by the FDA in late May as the only PET of PSMA-positive lesions in men with prostate cancer and suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated prostate-specific antigen level.

“The addition of POSLUMA to the highly respected NCCN guidelines is a major milestone for Blue Earth Diagnostics,” said David E. Gauden, DPhil, CEO of Blue Earth Diagnostics, in a press release. “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.”

With regard to PET imaging for identifying bone metastases, the guidelines state that flotufolastat F 18 should be used for “equivocal results on initial bone scan” along with sodium fluoride F 18, choline C 11, and fluciclovine F 18. As an alternative to bone scans, the guidelines indicate full-body imaging with PET/computed tomography or PET/magnetic resonance imaging using flotufolastat F 18, Ga-68 PSMA-11, or piflufolastat F 18 PSMA.

Flotufolastat F 18 joins piflufolastat F 18 PSMA and Ga-68 PSMA-11 as the other FDA-approved PSMA radiopharmaceuticals available for use.

“POSLUMA was developed to assist physicians in the detection and localization of prostate cancer,” said Eugene J. Teoh, MBBS, MRCP, FRCR, DPhil, CMO of Blue Earth Diagnostics, in the press release. “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.”