U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Approvals and Databases
  5. Drug Trials Snapshot: POSLUMA
  1. Drug Approvals and Databases

Drug Trials Snapshot: POSLUMA

HOW TO USE THIS SNAPSHOT

The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT

Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the POSLUMA Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

POSLUMA (flotufolastat F 18)
(Pos-lum-ah)
Blue Earth Diagnostics
Approval date: May 25, 2023

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

POSLUMA is a drug used for detecting specific cancer lesions in males with prostate cancer, specifically:

  • whose newly diagnosed cancer could be cured with the initial treatment, or
  • who have been treated for prostate cancer but have high prostate-specific antigen (PSA) in their blood. High PSA in the blood of these patients is a suspicious sign that cancer is coming back or spreading.

How is this drug used?

POSLUMA is an injection given by a health care provider in the vein (intravenous) in preparation for an imaging test that can help detect cancer (called positron emission tomography or PET scan imaging).

Who participated in the clinical trials?

The FDA approved POSLUMA based on evidence from two clinical trials (Trial 1/NCT04186819 and Trial 2/NCT04186845) of 747 male patients with prostate cancer. Trial 1 included 356 patients with newly diagnosed prostate cancer. Trial 2 included 391 patients who were treated for prostate cancer before, but there was suspicion that the cancer was spreading because of rising PSA.

Trial 1 was conducted at 34 sites in the United States, Finland, Germany, and the Netherlands. Trial 2 was conducted at 28 sites in the United States, Finland, and the Netherlands.

How were the trials designed?

There were two trials that evaluated benefits and side effects of POSLUMA.

Trial 1 enrolled patients who were recently diagnosed with unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer and were awaiting surgery for the removal of the prostate and the nearby lymph nodes.

Trial 2 enrolled patients who were already treated for prostate cancer but had rising PSA levels, suspicious for cancer recurrence.

The benefit of POSLUMA in Trial 1 was evaluated by measuring the successful detection of cancer lesions in the pelvis using POSLUMA PET or computed tomography (CT) imaging in comparison to post-surgery lymph tissue results (histopathology of the pelvic lymph nodes).

The benefit of POSLUMA in Trial 2 was evaluated by comparing the agreement in cancer lesion detection between images done with POSLUMA PET/CT imaging and one of the standard tests (imaging or tissue biopsy) for detecting cancer recurrence.

DEMOGRAPHICS SNAPSHOT:

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 747 (100%) male patients and 0 (0%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, other, and not reported patients were in the clinical trial. In total, 584 (78%) White patients, 91 (12%) Black or African American patients, 12 (2%) Asian patients, 6 (1%) other patients, and 54 (7%) not reported patients participated in the clinical trial.

Source: Adapted from FDA Review
*Other includes American Indian or Alaska Native (3 patients), Native Hawaiian or other Pacific Islander (2 patients), and other (1 patient).
 

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 284 (38%) patients younger than 65 years of age and 463 (62%) patients 65 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic, not Hispanic, and unknown patients were in the clinical trial. In total, 35 (5%) Hispanic or Latino patients, 653 (87%) not Hispanic or Latino patients, and 59 (8%) unknown patients participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

PET imaging done after POSLUMA injection showed sites of prostate-specific membrane antigen (PSMA) positive lesions in males with prostate cancer. PSMA is often present in prostate cancers.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

  • Sex: All trial participants were males; therefore, sex differences cannot be determined.
  • Race: The majority of participants in the clinical trials were White. Differences among races could not be determined because of the small number of participants from other races.
  • Age: POSLUMA worked similarly in patients younger and older than 65 years of age.

What are the possible side effects?

POSLUMA is a radioactive drug and will contribute to a patient’s long-term cumulative radiation exposure.

The most common side effects of POSLUMA are diarrhea, blood pressure increase, and injection site pain occurring in fewer than 1 in 100 patients.

Were there any differences in side effects among sex, race, and age?

  • Sex: All trial participants were males, therefore sex differences in side effects could not be determined.
  • Race: The majority of participants in the clinical trials were White. The occurrence of common side effects among races could not be determined due to the low number of side effects in any racial group.
  • Age: The occurrence of common side effects between patients younger and older than 65 years of age was similar.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

Back to Drug Trials Snapshots

 
Back to Top