Illuccix Gains FDA Nod for Earlier Prostate Cancer Detection

According to Telix Pharmaceuticals Limited, a biopharmaceutical company based in Melbourne that specializes in the development and marketing of therapeutic and diagnostic radiopharmaceuticals as well as related medical technologies. The US Food and Drug Administration (FDA) has authorized a label expansion for Illuccix, a 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 pertains to the third indication for Illuccix, which is the selection of patients who are prescribed PSMA1-directed therapy in accordance with the therapeutic products' prescribing information. Pluvicto 2 (lutetium Lu177 vipivotide tetraxetan) was approved by the US FDA with an enhanced authorization for use in patients with metastatic castration-resistant prostate cancer (mCRPC) following androgen receptor pathway inhibitor (ARPI) therapy but prior to chemotherapy. The clinical use of Illuccix is anticipated to rise by at least 20,000 scans per year as a result of RLT's approval for use earlier in the patient journey  

 Healthcare professionals like 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.”

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Kevin Richardson, CEO, Precision Medicine, Telix, said, “We’re pleased that the UU 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.”