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Cerianna (FLUOROESTRADIOL F-18)
Cerianna works by binding to estrogen receptors in the body, allowing for imaging of these receptors through positron emission tomography.
Cerianna, a fluorine-18 labeled estradiol developed by GE HealthCare, is currently marketed for the detection of ER-positive lesions in breast cancer. Its key strength lies in its mechanism of action, which allows for precise imaging of estrogen receptors through positron emission tomography, providing a unique advantage in the diagnosis of breast cancer. The primary risk is the presence of several same-class competitors, including off-patent sodium fluoride F-18, which may limit market share and revenue potential.
At a glance
| Generic name | FLUOROESTRADIOL F-18 |
|---|---|
| Sponsor | GE HealthCare |
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Target | Estrogen receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
Imagine your body's cells have locks on them, and estrogen receptors are the keys that fit into those locks. Cerianna is a special key that has a tiny bit of radioactive material attached to it, which allows doctors to see where the estrogen receptors are located in the body using a special camera.
Approved indications
- Detection of ER-positive lesions in breast cancer
Common side effects
- injection-site pain
- dysgeusia
Drug interactions
- SERMs (Selective Estrogen Receptor Modulators)
- SERDs (Selective Estrogen Receptor Degraders)
- elacestrant
- tamoxifen
- fulvestrant
Key clinical trials
- Diagnostic Accuracy and Safety Study of FES PET/CT in Assessment of ER Status of Recurrent or Metastatic Breast Cancer (PHASE3)
- FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy (PHASE2)
- A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer (PHASE2)
- Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy (PHASE2)
- [18F]FES PET/CT for the Detection of Distant Metastasis in Low-grade ER-positive Stage III Breast Cancer (PHASE2)
- Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in ER-positive Breast Cancer (PHASE2)
- Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer (PHASE2)
- Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in Invasive Lobular Carcinoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cerianna CI brief — competitive landscape report
- Cerianna updates RSS · CI watch RSS
- GE HealthCare portfolio CI