Axumin Efficacy
Efficacy that ensures confidence
Not an actual patient.
Axumin demonstrated high levels of accuracy across all regions1*
In a retrospective, observational study evaluating the efficacy and safety of Axumin PET imaging in patients with suspected biochemically recurrent prostate cancer1:
Interpretation agreed with histology
Interpretation did not agree with histology
Interpretation agreed with histology
Interpretation did not agree with histology
*105 images were evaluated by 3 independent readers who were unaware of the clinical details of each patient and whether the biopsy of the prostate bed or suspicious lesions on imaging were positive or negative for cancer. N is averaged across the 3 readers.
aAccuracy average of 3 blinded readers.
bAccuracy range across 3 blinded readers.
With Axumin,
seeing is believing
Image courtesy of Blue Earth Diagnostics.
Trust Axumin to provide confidence when PSMA PET may not
A prospective, single-center, single-arm cohort study evaluated Axumin PET scans following a negative or equivocal PSMA PET scan with 68Ga gozetotide or 18F-piflufolastat (N=50). All patients had biochemically recurrent prostate cancer with a PSA level ≥0.2 ng/mL. Scans were completed within 30 days of each other. Patients did not have anticancer treatment between scans.2
Detection rates across regions with Axumin2
†4 patients had bone metastasis, 2 had distant lymph nodes (outside the pelvis), 2 had visceral metastases (adrenal gland and lung), and 1 had distant lymph nodes and bone metastasis.
Axumin demonstrated high detection rates in patients with a negative or equivocal PSMA PET scan2
Axumin reveals details that clarify a path forward2
Patient history2
- PSA 0.4 ng/mL
- pT2c N0 at diagnosis
- Prostatectomy performed 5 months earlier
Scans2
- 18F-piflufolastat PET failed to detect activity in the pelvic lymph node
- Axumin PET (27 days later) detected activity in left obturator node
Outcome2
- Radiation therapy administered to left obturator node
- PSA dropped to <0.1 ng/mL
Axumin can play a vital role in the management of patients with a negative or equivocal PSMA PET scan2
71% (20/28)‡ of patients received a change in intended treatment approach based on a positive or negative Axumin scan2
‡28 out of 50 patients had sufficient information to determine change in clinical management.
Axumin reveals a path forward for patients with a negative or equivocal PSMA PET scan2
References: 1. Axumin. Package insert. Blue Earth Diagnostics Ltd; 2022. 2. Mallak N, Obala G, Lim JY. Role of 18F-fluciclovine PET/CT in patients with biochemical recurrence of prostate cancer and a negative PSMA PET/CT. Presented at the Society for Nuclear Medicine and Molecular Imaging (SNMMI) conference; June 21-24, 2025; New Orleans, LA.
INDICATION | IMPORTANT SAFETY INFORMATION
INDICATION
Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
IMPORTANT SAFETY INFORMATION
- Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
- Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
- Axumin use contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
- Adverse reactions were reported in ≤1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Axumin full Prescribing Information.