On October 19, 2022 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) 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 (Press release, Blue Earth Diagnostics, OCT 19, 2022, View Source [SID1234622195]). Details of selected oral and moderated poster presentations are listed below.

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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.

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.