MELBOURNE, Australia, March 16, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom lutetium-177 (177Lu) PSMA-directed therapy is indicated.[1] The label expansion means Illuccix is now approved in the U.S. to identify and select patients who are candidates for the only FDA-approved prostate-specific membrane antigen (PSMA)- directed radioligand therapy (Pluvicto),[2] providing doctors with critical information to guide patient management and help optimise treatment outcomes. To qualify for radioligand therapy, patients must be imaged with an approved gallium-based PSMA-PET agent.[3] As the only diagnostic agent for prostate cancer that combines the accuracy of gallium imaging with the reliability and flexibility of Telix's distribution network, the expanded indication for Illuccix has the potential to improve access to imaging for patients who are candidates for radioligand therapy. Kevin Richardson, Chief Executive Officer for Telix Americas said, "We welcome the FDA's decision to expand the label indication for Illuccix. This additional indication further demonstrates our continued commitment to support patients fighting prostate cancer and to empower the doctors who treat them. Clinicians now have the ability to use Illuccix in more stages of the patient journey, to confidently and accurately detect and help manage this disease." Use of Illuccix in the VISION Phase III study (ClinicalTrials.gov Identifier: NCT03511664)[4] helped doctors detect prostate cancer and identify the appropriate patients for PSMA-based radioligand therapy. Telix wishes to acknowledge collaboration with Novartis to deliver this outcome to patients. Dr Oliver Sartor, Medical Director at Tulane Cancer Center, added, "As radioligand therapy for prostate cancer becomes more prevalent, it is critical for doctors to understand who may or may not respond to those treatments. There's no doubt that appropriate selection of patients for PSMA targeted radioligand therapy is dependent on appropriate imaging. Ga-68 PSMA-11 PET was used in the VISION trial and, when used in combination with contrast-enhanced CT, represents a powerful tool for detecting prostate cancer and helping manage patients." It is estimated that 32,000 patients per year in the U.S. may be considered for PSMA-directed radioligand therapy.[5] About Illuccix Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent 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; with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level; for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. 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-stage products that aims to 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, has been approved by the FDA,[6] and by the Australian Therapeutic Goods Administration (TGA),[7] and by Health Canada.[8] Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: kyahn.williamson@telixpharma.com Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website. 2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved). [1]Specifically, lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy. [2]Pluvicto is a registered trademark of Novartis AG and/or its affiliates. [3]Per the Pluvicto package insert. [4]VISION study sponsored by Endocyte, a Novartis company. Telix provided Illuccix (TLX591-CDx) for 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) imaging. [5]American Cancer Society (ACS). Key Statistics for Prostate Cancer | Prostate Cancer Facts. 2023. [6]ASX disclosure 20 December 2021. [7]ASX disclosure 2 November 2021. [8]ASX disclosure 14 October 2022.