Patient Selection for PSMA-Targeted TherapyHealth Canada Approves Label Expansion for Telix's Illuccix(R) to Include PatientSelection for PSMA-Targeted Therapy MELBOURNE, Australia, Oct. 04, 2024 (GLOBE NEWSWIRE) -- Telix PharmaceuticalsLimited (ASX: TLX, Telix, the Company) today announces that Health Canada has approvedthe use of Illuccix(R) (kit for the preparation of gallium Ga 68 gozetotide injection) inselecting patients for PSMA(1) -targeted radionuclide therapy. The label expansion means that Illuccix is now approved in Canada to select patientswith progressive metastatic castration-resistant prostate cancer (mCRPC) for treatmentwith the only approved PSMA-targeted radionuclide therapy (lutetium ((177) Lu) vipivotidetetraxetan, or Pluvicto(R)(2) ). To qualify for PSMA-targeted therapy, patients must beimaged with an approved gallium-based PSMA-PET(3) agent(4) , such as Illuccix. The latest approval expands the clinical utility for Illuccix, which has beenapproved in Canada since October 2022 for staging and re-staging intermediate andhigh-risk prostate cancer, and localizing tumor tissue in recurrent prostate cancer(5) .Illuccix is available across Canada through Telix's partner Isologic InnovativeRadiopharmaceuticals (Isologic), whose distribution network services 265 hospitals andclinics nationwide. Dr. Francois Lamoureux, President of the Canadian Association of Nuclear Medicinesaid, "As targeted radionuclide therapy for prostate cancer becomes more prevalent inCanada, it is critical for doctors to understand who may or may not respond to thosetreatments. In the VISION trial(6) , (68) Ga-PSMA-11 PET/CT(7) was shown to be a powerfuland highly accurate tool for detecting prostate cancer and informing patient management." Andr? Gagnon, President of Isologic added, "PSMA-targeted theranostics are widelyconsidered to be the future of prostate cancer treatment. It is therefore tremendous thatwe can now offer Illuccix in this additional setting, for patients who are candidates forPSMA-targeted therapy, through our national network." Kevin Richardson, Chief Executive Officer, Telix Precision Medicine continued, "Wewelcome Health Canada's decision to expand the label for Illuccix. This will furtherimprove access to advanced prostate cancer imaging and provide doctors with criticalinformation to help make treatment decisions with confidence. This reflects Telix'songoing commitment to supporting patients with cancer and empowering the doctors who carefor them across more stages of the patient journey." Healthcare professionals in Canada can order Illuccix kits by [email protected] or by phone 1-877-505-4711 ext 0. Unit doses can be orderedfrom local radiopharmacies. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development andcommercialization of therapeutic and diagnostic radiopharmaceuticals and associatedmedical devices. Telix is headquartered in Melbourne, Australia, with internationaloperations in the United States, Europe (Belgium and Switzerland), and Japan. Telix isdeveloping a portfolio of clinical and commercial stage products that aims to addresssignificant unmet medical needs in oncology and rare diseases. Telix is listed on theAustralian Securities Exchange (ASX: TLX). Visit www.telixpharma.com for further information about Telix, including details ofthe latest share price, announcements made to the ASX, investor and analystpresentations, news releases, event details and other publications that may be ofinterest. You can also follow Telix on X and LinkedIn. About Illuccix(R) Telix's lead imaging product, gallium-68 ((68) Ga) gozetotide injection (also knownas (68) Ga PSMA-11 and marketed under the brand name Illuccix(R)), has been approved bythe U.S. Food and Drug Administration (FDA)(8) , by the Australian Therapeutic GoodsAdministration (TGA) (9) , and by Health Canada(10) . No other Telix product has receiveda marketing authorization in any jurisdiction. Indications and usage (Canada) Illuccix(R), after radiolabeling with gallium ((68) Ga), is indicated for use withpositron emission tomography (PET) of prostate specific membrane antigen (PSMA) positivelesions 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 here for approved product monograph in Canada. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] Legal Notices
YAY
(20min delay)