FDA Approves Imaging Agent for PSMA-Positive Lesions in Prostate Cancer With Suspected Metastasis


The approval of Posluma will help clinicians determine the extent of disease in men with prostate cancer and possible management options.

"FDA Approval: Developing Story" on an orange background

The Food and Drug Administration (FDA) approved Posluma (flotufolastat F 18) for the use in positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer with possible metastasis.

In particular, Posluma is an injectable imaging agent used for PET scans for cancer teams to determine whether the prostate cancer has spread to lymph nodes — considered metastasis — and to make management and treatment decisions based on those findings, according to a press release from Blue Earth Diagnostics, the manufacturer of Posluma.

This imaging agent is indicated for men with prostate cancer with potential metastasis who are candidates for therapy or who have suspected recurrence based on prostate-specific antigen (PSA) levels. Of note, approximately 25% of patients with primary prostate cancer may have pelvic lymph node metastases, which may be linked with a risk of disease recurrence, according to the release.

“Conventional imaging techniques such as CT and MRI are limited in the information they may provide,” said Dr. Brian F. Chapin, associate professor in the department of urology at The University of Texas MD Anderson Cancer Center in Houston and coordinating investigator of the LIGHTHOUSE study, in the release. “The LIGHTHOUSE study looked at unfavorable intermediate, high- and very high-risk patients who were scheduled for radical prostatectomy plus pelvic lymph node dissection prior to Posluma PET. The study showed that Posluma PET provided clinically valuable information prior to surgery that would likely result in management changes for these patients.”

This FDA approval was based on findings from two phase 3 trials: LIGHTHOUSE and SPOTLIGHT. Both trials were designed to determine Posluma’s safety and diagnostic performance in determining prostate cancer care in 747 patients with initial or recurrent prostate cancer. The side effects reported in both trials, which occurred in at least 0.4% of patients, included blood pressure increases, diarrhea and injection site pain, according to the release.

“The highly variable nature of recurrent prostate cancer presents clinical challenges, and up to 40% of patients who undergo radical prostatectomy, and up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years,” said Dr. David M. Schuster, professor of radiology and imaging sciences at Emory University School of Medicine in Atlanta, in the release. “The ability to determine the extent and location of recurrent disease is necessary to inform physicians and their patients for appropriate clinical management. The phase 3 SPOTLIGHT study … demonstrated that it offered precision diagnostic performance even at low PSA levels with an overall 83% detection rate.”

Posluma represents another tool to help clinicians made important treatment and management decisions for men with prostate cancer.

“We at ZERO Prostate Cancer are thrilled to see the approval of Posluma as an additional useful tool for staging prostate cancer,” said Shelby Moneer, vice president of advocacy and patient support at ZERO Prostate Cancer, in the release. “Determining if, when, or where prostate cancer has returned or spread is of the utmost importance for patients and their medical teams. The more patients know about their own diagnosis, the more empowered they are to seek personalized treatment plans. This new approval will, ultimately, give more options – and hope – to people impacted by prostate cancer.”

Posluma will be commercially available in early June 2023, according to the release.

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