First Patients Dosed with Illuccix® – Telix’s Approved Prostate Cancer Imaging Agent
INDIANAPOLIS, Indiana – April 14, 2022 – Telix announces the first commercial doses of its prostate cancer imaging agent, Illuccix®
Telix is pleased to announce the first commercial doses of its prostate cancer imaging agent, Illuccix® (kit for preparation of gallium Ga-68 gozetotide injection), also known as 68Ga-PSMA-11 injection.
As Illuccix rolls out nationally across the United States, physicians in Indianapolis (Indiana University School of Medicine), New York City, and Seattle are among the first to administer this new PSMA PET imaging agent that can help health care professionals (HCPs) diagnose the stage and spread of disease – an important step for the optimal care of men with prostate cancer.
Illuccix is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer with:
- suspected metastasis who are candidates for initial definitive therapy;
- suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Prostate cancer is the most common cancer in American men after skin cancer. According to the American Cancer Society, more than 268,000 men in the U.S. will be diagnosed this year with prostate cancer, and nearly 35,000 will die from their disease. Reliable and flexible diagnostic tools are essential for treatment teams in narrowing the gap between understanding the spread of disease and appropriate individualized treatment by healthcare professionals.
Illuccix is now widely available across the United States, significantly improving patient access to PSMA PET imaging. PSMA PET imaging is emerging as a standard of care in the U.S. having been included in latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer.
“Early detection and staging can help guide more informed disease management decisions. Tools such as Illuccix PSMA-PET are incredibly valuable as we look for better ways to manage prostate cancer in men,” said Dr. Michael Koch, Professor and Chair of the Department of Urology at the Indiana University School of Medicine and a physician-scientist at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center.
Professor Mark Green, Director of Radiopharmaceutical Sciences and Professor of Radiology & Imaging Sciences at the Indiana University School of Medicine, added “The success of Telix in gaining FDA-approval for kit-formulated 68Ga-PSMA-11 represents an innovation for prostate cancer patients. Telix is providing a much-needed avenue for widespread clinical access to PSMA-targeted PET for improved understanding of the location and extent of a patient’s disease. These imaging insights can be important as the physician develops an individualized treatment plan.”
Illuccix is now available to order from 117 pharmacies in the Telix network, providing coverage to approximately 85 percent of PET imaging sites across the U.S. with more sites to be added over the coming months.
Dr. Christian Behrenbruch, Group CEO and Managing Director of Telix Pharmaceuticals Limited said, “Telix is delivering on its promise to deliver product and a distribution network that will allow physicians and their patients greater convenience and flexible access to advanced prostate cancer imaging, a significant unmet medical need. Until now, PSMA-PET imaging has had patchy availability and limited patient scheduling flexibility. Illuccix changes this by enabling rapid on-site hospital preparation or convenient delivery from nearby commercial nuclear pharmacies.”
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IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Risk for Misdiagnosis
Image interpretation errors can occur with gallium Ga 68 gozetotide PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of gallium Ga 68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium Ga 68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.
The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.
Androgen deprivation therapy and other therapies targeting the androgen pathway
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.
See full U.S. Prescribing Information at illuccix-prescribing-information.pdf (illuccixhcp.com)