October 25, 2022 — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced presentations on Axumin (fluciclovine F 18) and investigational 18F-rhPSMA-7.3 at the upcoming American Society for Radiation Oncology (ASTRO) 2022 Annual Meeting, to be held in San Antonio, Texas, from October 23 to 26, 2022. Details of selected oral and moderated poster presentations are listed below.
An oral presentation on the investigational radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compound, 18F-rhPSMA-7.3, is being made at the conference. It includes additional results from the Company’s Phase 3 SPOTLIGHT study (NCT04186845) evaluating the impact of clinical factors on the detection rate of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Presentations on studies of Axumin (fluciclovine F 18) include interim analyses from a randomized trial of 18F-fluciclovine and 68Ga-PSMA PET/CT in post-prostatectomy radiotherapy, experience on the prognostic utility of 18F-fluciclovine PET after salvage radiotherapy, and timing and patterns of potentially salvageable recurrences after SBRT for localized prostate cancer. Additionally, the Company will host an Industry-Expert Theater event, “Emerging Data on the Impact of Axumin® (fluciclovine F 18) PET Imaging on Radiotherapy Decisions.” Details of selected oral and poster presentations by Blue Earth Diagnostics and its collaborators are listed below.
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. Currently, 18F-rhPSMA-7.3 is investigational and has not received regulatory approval.
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HIGHLIGHTED SCIENTIFIC PRESENTATIONS |
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Monday, October 24, 2022 |
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Investigational 18F-rhPSMA-7.3 presentation |
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Category: |
Genitourinary Cancer |
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Title: |
1049 Impact of Clinical Factors on 18F-rhPSMA-7.3 Detection Rates in Men with Recurrent Prostate Cancer: Findings from the Phase 3 SPOTLIGHT Study |
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Presenter: |
Benjamin Lowentritt, MD, Chesapeake Urology Associates, Towson, Md. |
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Session Type |
Quick Pitch |
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Session Title: |
QP 09 – GU 3 – Salvage, SABR and Protons for Prostate Cancer |
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Presentation Time: |
5:05 PM CT |
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Location: |
Henry B. Gonzalez Convention Center, Room 304 |
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Presentation No.: |
1049 |
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Tuesday, October 25, 2022 |
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Axumin (fluciclovine F 18) presentations |
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Category: |
Genitourinary Cancer |
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Title: |
Prognostic Utility of (18)F-Fluciclovine Positron Emission Tomography (FACBC) in Biochemically Recurrent (BCR) Prostate Cancer (PCa) Treated with Salvage Radiotherapy |
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Presenter: |
Graham Campbell, MD, University of Wisconsin Hospital and Clinics, Madison, Wis. |
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Session Title: |
PQ 06 – Poster Q&A 06 – Session 06 – Genitourinary Cancer, Patient Safety and Nursing |
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Presentation Time: |
2:30 PM CT |
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Location: |
Henry B. Gonzalez Convention Center, Exhibit Hall 1 |
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Presentation No.: |
2478 |
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Category: |
Genitourinary Cancer |
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Title: |
Timing and Patterns of Potentially Salvageable Recurrences Following SBRT for Clinically Localized Prostate Cancer Assessed by Preferential Amino Acid Uptake |
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Presenter: |
Michael Carrasquilla, MD, Department of Radiation Medicine, Medstar Georgetown University Hospital, Washington, DC |
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Session Title: |
Poster Q&A 06 – Session 06 – Genitourinary Cancer, Patient Safety and Nursing |
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Presentation Time: |
2:30 PM CT |
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Location: |
Henry B. Gonzalez Convention Center, Exhibit Hall 1 |
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Presentation No.: |
2479 |
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Category: |
Genitourinary Cancer |
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Title: |
Randomized Trial of 18F-fluciclovine vs 68Ga-PSMA PET/CT Guided Post-Prostatectomy Radiotherapy: Interim Volumetric and Patient-Reported Toxicity Analyses |
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Presenter: |
Vishal Ramesh Dhere, MD, Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Ga. |
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Session Title: |
Poster Q&A 06 – Session 06 – Genitourinary Cancer, Patient Safety and Nursing |
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Presentation Time: |
2:30 PM CT |
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Location: |
Henry B. Gonzalez Convention Center, Exhibit Hall 1 |
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Presentation No.: |
2489 |
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Blue Earth Diagnostics invites participants at the 2022 ASTRO Annual Meeting to attend the presentations above and visit the company at Exhibit Booth 4142. Blue Earth Diagnostics is hosting an Industry-Expert Theater event, “Emerging Data on the Impact of Axumin (fluciclovine F 18) PET Imaging on Radiotherapy Decisions,” with invited speaker Dr. Edward Obedian, MD, Radiation Oncologist, St. Francis Hospital, Long Island, NY. The event will be held on Sunday, October 23, 2022, from 11:00 AM to 12:00 PM CT, in Room 216, Meeting Level, Henry B. Gonzalez Convention Center. For full session details and scientific presentation listings, please see the ASTRO 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.
Full Axumin prescribing information is available at https://www.axumin.com/prescribing-information.pdf.
April 25, 2024 
