FDA approves expanded indication for Telix's Illuccix® for PSMA-directed therapy

16 March 2023 | Thursday | News

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]
Image Source : Public Domain

Image Source : Public Domain

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]


[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.


Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox


Forgot your password?



Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in