Health Canada Approves Label Expansion for Telix’s Illuccix® to Include Patient Selection for PSMA-Targeted Therapy
MELBOURNE, Australia, Oct. 04, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that Health Canada has approved the use of Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) in selecting patients for PSMA1-targeted radionuclide therapy.
The label expansion means that Illuccix is now approved in Canada to select patients with progressive metastatic castration-resistant prostate cancer (mCRPC) for treatment with the only approved PSMA-targeted radionuclide therapy (lutetium (177Lu) vipivotide tetraxetan, or Pluvicto®2). To qualify for PSMA-targeted therapy, patients must be imaged with an approved gallium-based PSMA-PET3 agent4, such as Illuccix.
The latest approval expands the clinical utility for Illuccix, which has been approved in Canada since October 2022 for staging and re-staging intermediate and high-risk prostate cancer, and localizing tumor tissue in recurrent prostate cancer5. Illuccix is available across Canada through Telix's partner Isologic Innovative Radiopharmaceuticals (Isologic), whose distribution network services 265 hospitals and clinics nationwide.
Dr. Francois Lamoureux, President of the Canadian Association of Nuclear Medicine said, “As targeted radionuclide therapy for prostate cancer becomes more prevalent in Canada, it is critical for doctors to understand who may or may not respond to those treatments. In the VISION trial6, 68Ga-PSMA-11 PET/CT7 was shown to be a powerful and highly accurate tool for detecting prostate cancer and informing patient management.”
André Gagnon, President of Isologic added, “PSMA-targeted theranostics are widely considered to be the future of prostate cancer treatment. It is therefore tremendous that we can now offer Illuccix in this additional setting, for patients who are candidates for PSMA-targeted therapy, through our national network.”
Kevin Richardson, Chief Executive Officer, Telix Precision Medicine continued, “We welcome Health Canada’s decision to expand the label for Illuccix. This will further improve access to advanced prostate cancer imaging and provide doctors with critical information to help make treatment decisions with confidence. This reflects Telix’s ongoing commitment to supporting patients with cancer and empowering the doctors who care for them across more stages of the patient journey.”
Healthcare professionals in Canada can order Illuccix kits by email or by phone 1-877-505-4711 ext 0. Unit doses can be ordered from local radiopharmacies.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).
Visit for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on and .
About Illuccix®
Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)8, by the Australian Therapeutic Goods Administration (TGA) 9, and by Health Canada10. No other Telix product has received a marketing authorization in any jurisdiction.
Indications and usage (Canada)
Illuccix®, after radiolabeling with gallium (68Ga), is indicated for use with positron emission tomography (PET) of prostate specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
- with suspected metastasis who are suitable for initial definitive therapy;
- with suspected recurrence with elevated serum prostate specific antigen (PSA) level; and
- for identification of patients with progressive metastatic castration-resistant prostate cancer (mCRPC), for whom PSMA-targeted therapy is indicated.
Illuccix is a Schedule C radiopharmaceutical product.
Click for approved product monograph in Canada.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email:
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1 Prostate-specific membrane antigen.
2 Pluvicto is a registered trademark of Novartis AG and/or its affiliates.
3 Imaging of prostate-specific membrane antigen with positron emission tomography.
4 Per the Pluvicto product monograph: Tumor PSMA expression should be verified before treatment with Pluvicto. In clinical trials, patients were selected on the basis of PSMA expression detected by PET diagnostic imaging using 68Ga-PSMA-11.
5 Telix ASX disclosure 14 October 2022.
6 ClinicalTrials.gov ID: . VISION study sponsored by Endocyte, a Novartis company. Telix provided Illuccix (TLX591-CDx) for PSMA-PET imaging.
7 Positron emission tomography/computed tomography.
8 Telix ASX disclosure 20 December 2021.
9 Telix ASX disclosure 2 November 2021.
10 Telix ASX disclosure 14 October 2022.
