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  5. Drug Trial Snapshot: CERIANNA
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Drug Trial Snapshot: CERIANNA

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age 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 health provider about the risks and benefits of a drug. Refer to the  CERIANNA Package Insert for complete information.

CERIANNA (fluoroestradiol F 18)
(Ser’ee’ an’ naa)
Zionexa US Corp
Approval date: May 20, 2020


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

CERIANNA is a drug for the visual detection of estrogen receptor (ER)-positive lesions in addition to tissue biopsy in patients with recurrent or metastatic breast cancer.

How is this drug used?

CERIANNA is injected into a vein by a healthcare provider in preparation for an imaging test (called positron emission tomography scan or PET scan) to detect the lesions. CERIANNA is to be used in addition to a tissue biopsy.

What are the benefits of this drug?

CERIANNA detects ER-positive lesions on PET scan images of patients with breast cancer.

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

Analyses of sex, race and age differences were not conducted.

What are the possible side effects?

CERIANNA is a radioactive drug which may increase the risk of lifetime radiation exposure.

The most common side effects of CERIANNA are injection site pain, and taste change.

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

Analyses of sex, race and age differences were not conducted.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved CERIANNA based on evidence from the trials data published in the medical journals. Detailed demographic data from these trials are, for the most part, incomplete.

Published data of 1207 patients from multiple trials conducted all over the world provided information about the side effects of CERIANNA.

Presented below are data from two trials that provided information for the benefits of CERIANNA. One trial was conducted at one site in South Korea and second trial was conducted at one site in the United States.

Figure 1. Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trial. In total, 109 women (100%) and 0 men participated in the clinical trial.)

FDA Review and Published Literature

Figure 2. Demographics by Race

: Pie chart summarizing the percentage of patients by race enrolled in the clinical trial. In total, 16 White (15%), 2 Black or African American  (2%), 90 Asian (82%) and 1 American Indian or Alaska Native (1%)

FDA Review FDA Review and Published Literature

Figure 3 summarizes the percentage of patients by age group in the clinical trial.

Figure 3. Demographics by Age

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total,  109 (100%) were 46 – 77 years)

FDA Review FDA Review and Published Literature

Figure 4. Demographics by Ethnicity

Pie charts summarizing ethnicity of patients enrolled in the clinical trial. In total,  19 patients were not Hispanic or Latino (17%).

FDA Review FDA Review and Published Literature

How were the trials designed?

The benefit of CERIANNA was based primarily on the data from two published clinical trials (Chae et al.2019 /NCT01986569 and Peterson et al.2014 /NCT00602043). In the trials, all patients with recurrent or metastatic ER-positive breast cancer received CERIANNA prior to PET scan imaging. In the trials, PET scan images were read as ER-positive and ER-negative by readers who had no knowledge about patient’s condition and compared to tissue biopsy results.

Side effects of CERIANNA were collected from multiple published trials.

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

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