Physicians in Indiana, New York Cityand Washington are among the first to administer Illuccix® – demonstrating coast-to-coast availability of this new imaging agent
Typically diagnosed in men over 50, prostate cancer is the second leading cause of cancer death in American men, after lung cancer
INDIANAPOLIS, April 14, 2022 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces 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 Statesphysicians in Indianapolis (Indiana University School of Medicine), New York Cityand 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 US 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 US 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 KochProfessor 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.
teacher Mark GreenDirector of Radiopharmaceutical Sciences and Professor of Radiology & Imaging Sciences at the Indiana University School of Medicineadded “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 US with more sites to be added over the coming months.
dr. Christian BehrenbruchGroup 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.”
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in belgium, Japan, Switzerlandand the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.
Telix’s lead product, Illuccix (kit for preparation of gallium Ga 68 gozetotide (also known as 68Ga PSMA-11) injection), has been approved by the US Food and Drug Administration (FDA), and by the Australian Therapeutic Goods Administration (TGA). Telix is also progressing marketing authorization applications for this investigational candidate in Europe and Canada.
INDICATIONS AND USE
Illuccix®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
- with suspected metastasis who are candidates for initial definitive therapy
- with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing [email protected]
See full US Prescribing Information at illuccix-prescribing-information.pdf (illuccixhcp.com)
Telix Investor Relations
Ms Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
E-mail: [email protected]
Telix Media Relations
Mr. Greg Kueterman
E-mail: [email protected]
This announcement has been authorized for release by Dr. Christian BehrenbruchManaging Director and Group Chief Executive Officer.
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 American Cancer Society.
 Positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions
 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.3.2022. Available at: https://www.nccn.org/guidelines/category_1.
 ASX disclosure December 20, 2021.
 ASX disclosure November 2, 2021.
 ASX disclosure December 10, 2021.
 ASX disclosure December 16, 2020.
SOURCE Telix Pharmaceuticals Limited