Australian TGA Approves Additional Indication for Telix's Illuccix® to Include Patient Selection for PSMA-Targeted Therapy

MELBOURNE, Australia, Oct. 8, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Australian Therapeutic Goods Administration (TGA) has approved the use of Illuccix® (kit for the preparation of ⁶⁸Ga-PSMA-11^[1] injection) to select patients for PSMA^[2]-targeted radionuclide therapy.

Illuccix remains the only PSMA-PET^[3] agent approved in Australia, manufactured to GMP^[4] standards, and listed on the Medicare Benefits Schedule (MBS) for imaging patients with prostate cancer. This label expansion means that it is now approved to select patients with metastatic prostate cancer for treatment with the only approved PSMA-targeted radionuclide therapy (Lu 177 vipivotide tetraxetan, or Pluvicto®^[5]). To qualify for PSMA-targeted therapy, patients should be identified by PSMA imaging^[6].

The latest approval expands the clinical utility for Illuccix, which has been approved in Australia since November 2021 for the initial staging of intermediate to high-risk patients with prostate cancer and the re-staging of patients with recurrent prostate cancer^[7]. 

Anne Savage, CEO Prostate Cancer Foundation of Australia commented, "Prostate cancer is the most commonly diagnosed cancer in Australia, with an estimated 26,368 men likely to be diagnosed in 2024. Of concern, around 4,000 of these newly diagnosed men will have Stage III or IV metastatic prostate cancer, which has spread beyond the prostate to other parts of the body, becoming more immediately life-threatening. Reflecting Telix's continued innovation and commitment to patient care, this additional approved indication for Illuccix will help fulfil a critical unmet need by facilitating access to timely and effective treatment with PSMA-targeted therapy."

Professor Andrew Scott AM, Director of the Department of Molecular Imaging and Therapy at Austin Health, Melbourne added, "In the VISION trial^[8], Telix's PSMA-PET agent was used to help doctors detect prostate cancer and identify appropriate patients for PSMA-targeted radionuclide therapy with Lu 177 vipivotide tetraxetan, based on a theranostic approach. It is great news for patients that Illuccix is now approved for this use in Australia, with clinicians able to use this product in more stages of the patient journey, to confidently and accurately detect and help manage this disease."

Raphaël Ortiz, CEO Telix International continued, "We welcome the TGA's decision to approve Illuccix for selecting patients for PSMA-targeted therapy. Historically, many radiopharmaceuticals in Australia – including PSMA theranostics – have been produced in-house not subject to regulatory approval or GMP standards. With Illuccix now registered on the ARTG^[9] for broader use, widely available and reimbursed, Telix is actively working with clinical sites to ensure patients have access to the only approved PSMA-PET imaging agent in Australia.

"Men with prostate cancer deserve to be given products that have been through clinical trials and are subject to rigorous evaluation by regulatory authorities for quality, effectiveness, and safety profile. By accurately identifying patients most likely to respond to therapy, Illuccix has the potential to reduce the mortality burden of prostate cancer in Australia – a burden which claims the lives of 3,743 men every year."

Illuccix is available to order via Telix's distribution partner in Australia, Global Medical Solutions Australia, at the following link: https://www.globalmedicalsolutions.com.au/pages/contact-us

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation 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 www.telixpharma.com 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 X and LinkedIn.

About Illuccix®

Telix's lead imaging product, Ga-68 Glu-urea-Lys(ahx)-hbed-CC 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)^[10], by the Australian Therapeutic Goods Administration (TGA) ^[11], and by Health Canada^[12]. No other Telix product has received a marketing authorisation in any jurisdiction.

Indications and usage (Australia)

Illuccix®, after radiolabelling with Ga-68, is a radioactive diagnostic agent indicated for use with PET imaging combined with computed tomography (CT) in patients with prostate cancer:

• who are at risk of metastasis and who are suitable for initial definitive therapy;
• who have suspected recurrence based on elevated serum prostate specific antigen (PSA) level; and
• for the selection of patients with metastatic prostate cancer in whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com

Legal Notices

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain 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", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. 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 Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix'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 trials, 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 for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; 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.

©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.