On February, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported presentations on Axumin (fluciclovine F 18) at the upcoming ASCO (Free ASCO Whitepaper) 2021 Genitourinary Cancers Symposium (ASCO GU), from February 11 to 13, 2021, to be held in a virtual format (Press release, Blue Earth Diagnostics, FEB 8, 2021, View Source [SID1234574724]). Details of selected oral poster presentations are listed below.
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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. Axumin is a registered trademark of Blue Earth Diagnostics, Ltd., or its related companies. All other marks are the property of their respective owners.
Highlighted Axumin (Fluciclovine F 18) Scientific Presentations
All ASCO (Free ASCO Whitepaper) GU presentations are available beginning Thursday, February 11, 2021, at 8 a.m. ET.
Track: Prostate Cancer – Advanced
Title: Diagnostic utility of (18)f-fluciclovine positron emission tomography (FACBC) in biochemically recurrent (BCR) prostate cancer (PCa) based on prior primary treatment modality for localized disease and the impact of FACBC findings on treatment selection.
Author(s) Marina N. Sharifi, Petra Lovrec, Jens C. Eickhoff, Aria Kenarsary, David F. Jarrard, John Floberg, Steve Y. Cho, Christos Kyriakopoulos, Hamid Emamekhoo
Session: Poster session
Abstract: 34
Track: Prostate Cancer – Advanced
Title: Use of 18F-fluciclovine PET/CT (FluPET) for prostate cancer (PC): Initial results from a prospective registry at a tertiary academic center.
Author(s): Risa L. Wong, Heather H. Cheng, Sarah K. Holt, Nathan Conrad, Hannah Loesch, Sara Fernandez, Rameen Sahoo, Zoya Bauer, Andrea Toulouse, Petros Grivas, Todd Yezefski, Kenneth J. Russell, Jonathan L. Wright, Michael T. Schweizer, Robert B. Montgomery, Jean H. Lee, Delphine L. Chen, Jing Zeng, Daniel W. Lin, Evan Y. Yu
Session: Poster session
Abstract: 29
Track: Trials in Progress – Advanced Prostate Cancer
Title: 18F-fluciclovine positron emission tomography (PET) in metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate.
Author(s): Pedro C. Barata, Charlotte Manogue, Ellen Jaeger, Malcolm Light, Patrick Cotogno, Elisa M. Ledet, Janeiro Goffin, Jodi L. Layton, Brian E. Lewis, A. O. Sartor
Session: Poster session
Abstract: TPS171
Blue Earth Diagnostics invites participants at the ASCO (Free ASCO Whitepaper) 2021 Genitourinary Cancers Symposium (ASCO GU) to attend the presentations above and to visit Blue Earth Diagnostics’ commercial exhibit in the Virtual Exhibit hall. For full session details and scientific presentation listings, please see the ASCO (Free ASCO Whitepaper) GU online program here.
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.