Telix Wins US Approval to Broaden Illuccix Use, Paving Way for 20,000 More Prostate Cancer Scans Annually

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ:TLX, "Telix", "the Company") today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved a label expansion for Illuccix® (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include patient selection for radioligand therapy (RLT) in the pre-taxane setting.

The update applies to Illuccix's third indication, for selection of patients who are indicated for PSMA1-directed therapy as described in the Prescribing Information of the therapeutic products. The label expansion follows the FDA's approval of an expanded label for Pluvicto®2 (lutetium Lu177 vipivotide tetraxetan) for use in metastatic castration-resistant prostate cancer (mCRPC) patients after treatment with androgen receptor pathway inhibitor (ARPI) therapy and before chemotherapy3. With RLT now approved for use earlier in the patient journey, the clinical utilization of Illuccix® is expected to increase by at least 20,000 scans annually4.

Scott T. Tagawa, MD, a genitourinary (GU) oncologist in New York said, "It is pleasing to see the ability to use gallium-68 PSMA-PET for patient selection expanded. This empowers clinicians to make more informed, personalized decisions earlier in the disease course and access life-prolonging targeted radionuclide therapy for more patients with prostate cancer."

Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, "We're pleased that the U.S. label for Illuccix has been expanded to support patient selection for RLT in the pre-taxane setting, aligning with the evolving treatment landscape. PSMA-PET imaging has become a standard of care in the detection and management of prostate cancer. With this update, patients can now benefit from the high diagnostic accuracy of Illuccix to identify those most likely to respond to PSMA-targeted therapy, even earlier in their treatment journey."