FDA Approves Expanded Indication for Telix’s Illuccix® to Include Patient Selection for PSMA-Directed Radioligand Therapy

Indianapolis, IN (United States) | 16 March 2023

Telix Pharmaceuticals 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 177Lu 177 PSMA-directed therapy is indicated.[1]

The label expansion means Illuccix is now approved in the U.S. to 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 help optimize and guide treatment decisions. To qualify for radioligand therapy, patients must be imaged with an approved gallium-based PSMA-PET agent.[3]

As the only diagnostic agent for suspected metastatic and recurrent 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 guide patient management.”

It is estimated that 32,000 patients per year in the U.S. may be considered for PSMA-directed radioligand therapy.[5]

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ILLUCCIX, after radiolabeling with Ga 68, is for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

  • With suspected metastasis who are candidates for initial definitive therapy 
  • With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
  • For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated



Risk for Misinterpretation

Image interpretation errors can occur with ILLUCCIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy

The performance of ILLUCCIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of ILLUCCIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Imaging to Select Patients for Lutetium Lu 177 Vipivotide Tetraxetan Therapy

The interpretation of ILLUCCIX PET may differ depending on imaging readers. ILLUCCIX PET interpretations to select patients for lutetium Lu 177 vipivotide tetraxetan therapy may be more consistent when judging gallium Ga 68 gozetotide uptake in any one tumor lesion compared to judging uptake for all lesions larger than size criteria. Multidisciplinary consultation to select patients for lutetium Lu 177 vipivotide tetraxetan therapy is recommended, particularly for ILLUCCIX imaging that a single reader finds borderline or difficult to interpret, or when patient eligibility hinges only on judgment of gallium Ga 68 gozetotide uptake for all lesions larger than size criteria.

Radiation Risks

Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.


The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%).

Adverse reactions occurring at a rate of < 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills.


Androgen deprivation therapy and other therapies targeting the androgen pathway

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

Please note that this information is not comprehensive.
Please see the Full Prescribing Information at illuccix.com/prescribinginformation

You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

[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.​