Australian TGA Accepts Telix’s Prostate Cancer Imaging Product Submission and Commences Priority Evaluation Process
Melbourne (Australia) – 14 April 2021. Telix announces the Australian Therapeutic Goods Administration has accepted its prostate cancer imaging product submission and commenced the priority evaluation process
Telix is pleased to announce that the Australian Therapeutic Goods Administration (TGA) has accepted the Company’s submission for the registration of its prostate cancer imaging product Illuccix® (TLX591-CDx, Kit for the preparation of 68Ga-PSMA-11 injection) and has now commenced the priority evaluation process.
Under the priority registration pathway, the TGA will evaluate Telix’s submission to register Illuccix® on the Australian Register of Therapeutic Goods (ARTG) with a target timeframe of 150 working days and an indicative decision date (‘Milestone 7 date’) of 12 November 2021. Together with regulatory submissions in Canada, the European Union and the United States, Illuccix® presently has regulatory reviews in progress in 17 countries globally.
Telix CEO, Dr. Christian Behrenbruch stated “We are pleased that the TGA has accepted our submission for the registration of Illuccix® and has now commenced the priority evaluation phase. This brings us significantly closer to our goal of providing widespread access to state-of-the-art prostate cancer imaging for Australian men living with prostate cancer. Should we be successful in gaining TGA registration of Illuccix® in Australia, we would also anticipate filing a New Medical Application with Medsafe in New Zealand under the abbreviated evaluation process for medicines approved by recognised overseas regulators. We are committed to providing access to Illuccix® for all men living with prostate cancer, regardless of where they reside.”
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