The efficacy of Axumin® (fluciclovine F 18) injection was established in 2 separate clinical studies1

The FDA-approved prescribing information provides summaries from 2 clinical studies of Axumin, including an evaluation of 105 images by 3 independent readers who were unaware of the clinical details of each patient and whether the biopsy of the prostate/prostate bed or suspicious lesions on imaging were positive or negative for cancer. The charts illustrate the correctly predicted biopsy findings.

Clinical studies were based on patients with elevated prostate specific antigen (PSA) levels following radical prostatectomy and/or radiotherapy.1

Trial results

Patient PSA levels seemed to affect results with, in general, lower PSA levels correlating more frequently with negative scans than with positive scans.1

Axumin PSA levels scan correlation
Efficacy of Axumin – clinical trial results

​​​​​​Average performance of Axumin in patients with biochemically recurrent prostate cancer1

On average, the readers correctly predicted the biopsy results for 77% of the images (range: 75%–79%). For the approximately 1/3 of the images with suspicious lesions outside the region of the prostate bed, 90% of the images were confirmed by histology.1 

Charts illustrate findings from clinical trial 1 only. Information adapted from Section 14, Table 4, of Prescribing Information.

Efficacy was confirmed in a multicenter retrospective study2

Axumin can detect recurrence in the prostate or prostate bed in 39% of scans, pelvic lymph nodes in 33%, metastatic sites outside of the pelvis in 26%, and skeletal involvement in 9%

Results from this multicenter retrospective study show an overall detection rate of recurrent prostate cancer of 68% (403 of 595 scans)2

Overall detection rate of ~40% in patients with PSA levels ≤0.79 ng/mL, rising to ~60% at PSA 0.80-2.032

Detection rates based on PSA quartiles

Impact of PSA on fluciclovine F 18 PET/CT detection rate at subject and region levels in combined data set.

In a recent study, Axumin demonstrated a high detection rate of prostate cancer recurrence3*

This was a retrospective cohort study of 152 men who had suspected biochemical recurrence of prostate cancer after receiving initial treatment and had an Axumin scan. Detection rates (DR) were calculated for whole-body, prostate and prostate bed, and extraprostatic locations. The influence of different factors (absolute PSA level, PSA kinetics, the Gleason score, and Gleason grade groups) on the DR were evaluated.

Initial therapy received by patients (N=152)

Initial Therapy Chart

Note: Data are number of patients.
Abbreviations: BT, brachytherapy; EBRT, external beam radiation therapy; HT, hormone therapy; RP, radical prostatectomy.

Axumin demonstrated an overall (whole-body) detection rate of 81%

Of the 152 patients in the cohort: 

  • 92 (61%) had positive findings within the prostate and prostate bed
  • 83 (55%) had positive findings in the extraprostatic region (lymph nodes, bone, viscera, or a combination of these locations)

Axumin detection rates were consistent across patients with or without hormone therapy

Axumin Detection Rates Graph

*Information on the presence or absence of disease was not available for most patients, therefore, the diagnostic performance of fluciclovine F 18 PET/CT could not be evaluated.

Axumin detection rates correlated with increasing PSA levels3

The Axumin detection rate increased linearly with an increasing PSA level (P<.001).

Axumin Increasing PSA Graph

Detection rate of extraprostatic disease (including pelvic and extrapelvic lymph nodes, bone, lung, and liver lesions) was 55%.

PSA doubling time or velocity had no statistically significant effect on the detection rates of Axumin

Likelihood of detecting extraprostatic lesions with positive Axumin findings significantly increased with an increasing Gleason score

Safety data were not reported

References:

  1. Axumin [package insert]. Oxford, UK: Blue Earth Diagnostics Ltd; 2016.
  2. Bach-Gansmo T, Nanni C, Nieh PT, et al. Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine (18F) Positron Emission Tomography/Computerized Tomography Imaging in the Staging of Biochemically Recurrent Prostate Cancer. J Urol. 2017;197:676-683. 
  3. Savir-Baruch B, Lovec P, Solanki AA, et al. Fluorine-18-labeled fluciclovine PET/CT in clinical practice: factors affecting the rate of detection of recurrent prostate cancer. AJR Am J Roentgenol. 2019;213(4):851-858.

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.