On June 8, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals reported presentations at the upcoming Society of Nuclear Medicine and Molecular Imaging Annual Meeting (SNMMI), to be held in a virtual format from June 11 to 15, 2021 (Press release, Blue Earth Diagnostics, JUN 8, 2021, View Source [SID1234583721]). Results to be presented include an interim analysis of the comparative diagnostic performance of Axumin (fluciclovine F 18) PET in biochemical recurrence of prostate cancer, an evaluation of its impact on patient management in oligometastatic disease, and its performance in patients with recurrent prostate cancer who have suffered multiple treatment failures, among others. Details of the presentations to be given by Blue Earth Diagnostics collaborators are listed below. Additionally, the Company will host a satellite symposium, "The Role of PET in Post-Prostatectomy Radiotherapy," which will review the role of PET in guiding management decisions and influencing treatment outcomes and results of the EMPIRE-1 randomized trial.
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NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
Highlighted Axumin (Fluciclovine F 18) Scientific Presentations
All SNMMI presentations are available beginning Friday, June 11, 2021.
Title:
Positivity rates of 18F-fluciclovine PET/CT and 68Ga-PSMA PET/CT: Interim analysis of a secondary endpoint from a randomized trial
in patients with biochemical recurrence post-prostatectomy
Author(s):
Olayinka Abiodun-Ojo, Ashesh Jani, Omotayo Adediran, Akinyemi Akintayo, Bridget Fielder, Subir Goyal, Raghuveer Halkar and David Schuster
Session:
Poster – Physician/Pharm
Abstract:
1130
Title:
Incidence and Impact of Oligometastatic Disease Detected on 18F-Fluciclovine PET/CT in Biochemically Recurrent Prostate Cancer
Author(s):
Redmond-Craig Anderson, Erik Velez and Hossein Jadvar
Session:
Poster – Physician/Pharm
Abstract:
1332
Title:
Diagnostic Performance of F-18 Fluciclovine PET/CT in Prostate Cancer Patients with rising PSA Level < =0.5 ng/ml after multiple
treatment failures
Author(s):
Ajalaya Teyateeti, Achiraya Teyateeti, Gregory Ravizzini, Guofan Xu, Chad Tang, Shi-Ming Tu, Homer Macapinlac and Yang Lu
Session:
Poster – Physician/Pharm
Abstract:
1361
Title:
Single atypical metastases from Prostate Cancer as detected with Fluciclovine PET/CT: A Pictorial Essay
Author(s):
Amer Alassi, Peter Temsah, Leonard Goldfarb, Razi Muzaffar and Medhat Osman
Session:
Poster – Educational Exhibits
Abstract:
2042
Title:
Blanching defects at the pressure points: a potential pitfall in dynamic Total-Body PET/CT studies
Author(s):
Kristin McBride, Edwin Leung, Heather Hunt, Mike Nguyen, Benjamin Spencer, Simon Cherry, Ramsey Badawi, Lorenzo Nardo and Yasser Abdelhafez
Session:
Oral – Technologist
Abstract:
186
Blue Earth Diagnostics invites participants at the 2021 SNMMI Annual Meeting to attend the presentations above and to visit the Company’s virtual Commercial Exhibit Booth. Blue Earth Diagnostics also has a Medical Affairs information booth at SNMMI, where attendees can learn about ongoing clinical trials. The Company is also hosting a Satellite Symposium, "The Role of PET in Post-Prostatectomy Radiotherapy," with invited speaker Dr. Ashesh Jani, MD, MSEE, FASTRO, James C. Kennedy Professor, Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Ga. The symposium will be held on Saturday, June 12, 2021, from 11:45 a.m. – 12:45 pm ET. For more information about the meeting, please see the SNMMI online program here. Information on abstract presentations is available here.
U.S. Indication and Important Safety Information About Axumin
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.
Full U.S. Axumin prescribing information is available at:
About Axumin (fluciclovine F 18)
Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications including in neuro-oncology.