Illuccix Approved in U.S. for Patient Selection for Pre-Taxane RLT
- Label expansion allows earlier patient selection for radioligand therapy, potentially improving treatment outcomes
- Expected increase of 20,000 additional scans annually, indicating significant market expansion
- Aligns with FDA's approval of Pluvicto, strengthening Illuccix's market position
- Demonstrated safety profile with minimal adverse reactions in clinical studies
- Image interpretation errors can occur with Illuccix PET
- Performance affected by serum PSA levels and disease site location
- Contributes to patient's long-term cumulative radiation exposure
Insights
FDA expanded Illuccix's label for pre-chemotherapy patient selection, potentially increasing scan volume by 20,000 annually.
The FDA's approval to expand Illuccix's label represents a significant advancement in prostate cancer management. This gallium-68 PSMA-PET imaging agent can now be used to select patients for radioligand therapy before taxane-based chemotherapy, moving its application earlier in the treatment sequence. This aligns with the recent FDA approval of Pluvicto for use after androgen receptor pathway inhibitor therapy but before chemotherapy in metastatic castration-resistant prostate cancer patients.
The clinical implications are substantial. By identifying PSMA-positive lesions earlier, oncologists can now make more informed decisions about which patients are appropriate candidates for PSMA-targeted radioligand therapy before subjecting them to chemotherapy's significant side effects. This precision medicine approach allows for more personalized treatment sequencing, potentially improving outcomes by delivering the right treatment to the right patient at the optimal time.
The company projects this label expansion will increase Illuccix utilization by at least 20,000 scans annually. This estimate appears reasonable given the incidence of metastatic castration-resistant prostate cancer and the growing adoption of PSMA-PET imaging as the standard of care in prostate cancer management. The approval strengthens Illuccix's position in the diagnostic landscape by ensuring its continued relevance as treatment paradigms evolve. Importantly, this allows for earlier identification of patients who may benefit from targeted radioligand therapy, potentially improving patient outcomes while expanding Telix's market reach.
FDA label expansion increases Illuccix's addressable market by 20,000 annual scans, strengthening Telix's market position.
This FDA label expansion represents a meaningful commercial opportunity for Telix Pharmaceuticals. The company explicitly states that clinical utilization of Illuccix is expected to increase by at least 20,000 scans annually due to this approval. This volume increase directly translates to revenue growth, as each additional scan represents a billable procedure using Telix's product.
The timing is strategically advantageous, as it aligns Illuccix's label with the recent expansion of Pluvicto's indication to earlier in the treatment pathway. By securing this complementary approval, Telix ensures its diagnostic remains the companion to an expanding therapeutic indication. This demonstrates Telix's ability to navigate the regulatory landscape effectively to maintain market relevance.
From a competitive standpoint, this approval strengthens Telix's position in the PSMA-PET imaging market. While not explicitly mentioned in the release, Illuccix competes with other PSMA-PET tracers, and this expanded label maintains its clinical utility in the evolving treatment paradigm. The approval further cements PSMA-PET imaging as a standard of care in prostate cancer management, with Illuccix positioned as a leading option.
The expanded indication moves Illuccix use earlier in the patient journey, which could lead to greater market penetration and patient access. This helps secure Telix's revenue stream as treatment paradigms evolve, creating a more sustainable long-term market position in the prostate cancer diagnostic landscape.
MELBOURNE, Australia and INDIANAPOLIS, June 23, 2025 (GLOBE NEWSWIRE) -- 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.”
INDICATIONS AND USAGE
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 who are indicated for PSMA-directed therapy as described in the Prescribing Information of the therapeutic products
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
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.
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.
ADVERSE REACTIONS
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 <
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 ≥
DRUG INTERACTIONS
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 here.
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.
Dr. Tagawa has served as a paid consultant to Telix and his institution has received research funding.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
Telix Media Relations (U.S.)
Eliza Schleifstein
ES Media Relations
Email: eliza@schleifsteinpr.com
Phone: 917-763-8106
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, is approved and commercially available in multiple countries globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA5.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.
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1 Prostate-specific membrane antigen
2 Pluvicto is a registered trademark of Novartis AG and/or its affiliates.
3 28 March 2025, FDA Statement: for patients who have been treated with ARPI therapy and are considered appropriate to delay taxane-based chemotherapy.
4 Based on licensed indication for Pluvicto in mCRPC patients who have been treated with androgen receptor (AR) pathway inhibition.
5 Telix ASX disclosure 21 March 2025.
FAQ
What is the new FDA approval for Telix's Illuccix (TLX)?
How many additional scans is Illuccix expected to perform after the label expansion?
What are the main indications for Illuccix use in prostate cancer?
What are the most common side effects of Illuccix?
How does the Illuccix label expansion relate to Pluvicto?
