FDA Approves New Prostate Cancer Imaging Agent Gozellix®
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has received FDA approval for Gozellix®, a next-generation PSMA-PET imaging agent for prostate cancer. The product is designed for PET scanning of PSMA positive lesions in men with suspected metastasis or recurrence.
Key features of Gozellix® include:
- Extended shelf life up to 6 hours
- Wider distribution radius compared to existing products
- Enhanced efficiency and scheduling flexibility for scanning clinics
- Expected full reimbursement with reduced/no patient co-insurance
The product will be available alongside Telix's first-generation product Illuccix®, targeting the 3.4 million men living with prostate cancer in the U.S. who currently have access to PSMA-PET imaging. The approval aims to improve accessibility to precision medicine scanning, particularly in underserved populations.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) ha ricevuto l'approvazione della FDA per Gozellix®, un agente di imaging PSMA-PET di nuova generazione per il cancro alla prostata. Il prodotto è progettato per la scansione PET di lesioni positive al PSMA negli uomini con sospetta metastasi o recidiva.
Le caratteristiche principali di Gozellix® includono:
- Durata di conservazione estesa fino a 6 ore
- Raggio di distribuzione più ampio rispetto ai prodotti esistenti
- Maggiore efficienza e flessibilità nella programmazione per le cliniche di scansione
- Rimborso completo previsto con ridotto o assente co-pagamento da parte del paziente
Il prodotto sarà disponibile insieme al primo prodotto di Telix, Illuccix®, rivolto ai 3,4 milioni di uomini che vivono con il cancro alla prostata negli Stati Uniti, che attualmente hanno accesso all'imaging PSMA-PET. L'approvazione mira a migliorare l'accessibilità alla scansione di medicina di precisione, in particolare nelle popolazioni svantaggiate.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) ha recibido la aprobación de la FDA para Gozellix®, un agente de imagenología PSMA-PET de nueva generación para el cáncer de próstata. El producto está diseñado para la exploración PET de lesiones positivas al PSMA en hombres con sospecha de metástasis o recurrencia.
Las características clave de Gozellix® incluyen:
- Vida útil extendida de hasta 6 horas
- Mayor radio de distribución en comparación con los productos existentes
- Mayor eficiencia y flexibilidad en la programación para clínicas de exploración
- Reembolso completo esperado con coaseguro reducido o nulo para el paciente
El producto estará disponible junto con el primer producto de Telix, Illuccix®, dirigido a los 3.4 millones de hombres que viven con cáncer de próstata en EE.UU. que actualmente tienen acceso a la imagenología PSMA-PET. La aprobación tiene como objetivo mejorar la accesibilidad a la exploración de medicina de precisión, particularmente en poblaciones desatendidas.
텔릭스 제약 (ASX: TLX, 나스닥: TLX)이 전립선암을 위한 차세대 PSMA-PET 이미징 제제인 고젤릭스(Gozellix®)에 대한 FDA 승인을 받았습니다. 이 제품은 전이 또는 재발이 의심되는 남성의 PSMA 양성 병변에 대한 PET 스캔을 위해 설계되었습니다.
고젤릭스(Gozellix®)의 주요 특징은 다음과 같습니다:
- 최대 6시간의 연장된 유통 기한
- 기존 제품에 비해 넓은 배급 반경
- 스캔 클리닉을 위한 향상된 효율성과 일정 유연성
- 환자의 공동보험이 줄어들거나 없는 상태에서의 전액 환급 예상
이 제품은 텔릭스의 1세대 제품인 일루칙스(Illuccix®)와 함께 제공되며, 현재 PSMA-PET 이미징에 접근할 수 있는 미국 내 전립선암 환자 340만 명을 대상으로 합니다. 이번 승인은 특히 소외된 인구에서 정밀 의학 스캔에 대한 접근성을 향상시키는 것을 목표로 하고 있습니다.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) a reçu l'approbation de la FDA pour Gozellix®, un agent d'imagerie PSMA-PET de nouvelle génération pour le cancer de la prostate. Le produit est conçu pour l'imagerie PET des lésions positives au PSMA chez les hommes présentant des métastases ou une récidive suspectées.
Les principales caractéristiques de Gozellix® incluent:
- Durée de conservation prolongée allant jusqu'à 6 heures
- Rayon de distribution plus large par rapport aux produits existants
- Efficacité accrue et flexibilité de planification pour les cliniques d'imagerie
- Remboursement complet attendu avec coassurance réduite ou nulle pour le patient
Le produit sera disponible en même temps que le premier produit de Telix, Illuccix®, ciblant les 3,4 millions d'hommes vivant avec un cancer de la prostate aux États-Unis qui ont actuellement accès à l'imagerie PSMA-PET. L'approbation vise à améliorer l'accessibilité à l'imagerie de médecine de précision, en particulier dans les populations mal desservies.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) hat die FDA-Zulassung für Gozellix® erhalten, ein PSMA-PET-Bildgebungsagent der nächsten Generation für Prostatakrebs. Das Produkt ist für PET-Scans von PSMA-positiven Läsionen bei Männern mit Verdacht auf Metastasen oder Rezidiv konzipiert.
Die Hauptmerkmale von Gozellix® umfassen:
- Erweiterte Haltbarkeit von bis zu 6 Stunden
- Größerer Verteilungsradius im Vergleich zu bestehenden Produkten
- Erhöhte Effizienz und Flexibilität in der Terminplanung für Scan-Kliniken
- Erwartete volle Erstattung mit reduziertem oder keinem Selbstbehalt für den Patienten
Das Produkt wird zusammen mit dem ersten Produkt von Telix, Illuccix®, verfügbar sein, das sich an die 3,4 Millionen Männer richtet, die in den USA mit Prostatakrebs leben und derzeit Zugang zu PSMA-PET-Bildgebung haben. Die Genehmigung zielt darauf ab, den Zugang zur Präzisionsmedizin-Bildgebung, insbesondere in unterversorgten Bevölkerungsgruppen, zu verbessern.
- FDA approval secured for next-generation PSMA-PET imaging agent
- Extended 6-hour shelf life enables wider market reach
- Expected full reimbursement with reduced/no patient co-insurance
- Potential to expand market access to 3.4 million prostate cancer patients
- Enhanced operational efficiency for scanning clinics
- Product requires careful handling due to radiation exposure risks
- Image interpretation errors possible with false positives/negatives
- Performance affected by PSA levels and Gleason score
- Potential hypersensitivity reactions to sulfites in some patients
Insights
The FDA approval of Telix Pharmaceuticals' Gozellix® represents a significant advancement in addressing healthcare access disparities within prostate cancer diagnostics. The strategic importance of this approval cannot be overstated, especially considering the reimbursement profile.
What makes this development particularly impactful is the expected full reimbursement with reduced or eliminated patient co-insurance. This financial structure directly addresses one of the most persistent barriers to precision medicine adoption in oncology. For underserved populations who disproportionately face challenges accessing advanced diagnostics, this approval creates a pathway to gold-standard imaging that was previously unavailable.
The logistics improvements - specifically the extended 6-hour shelf life and wider distribution radius - solve a fundamental healthcare delivery problem. PSMA-PET imaging has become standard of care, yet the article notes only a fraction of the 3.4 million American men with prostate cancer have accessed these scans. This disparity exists largely because gallium-based tracers have significant production and distribution limitations.
By enabling delivery to imaging centers previously unreachable, Telix is effectively expanding the U.S. diagnostic infrastructure without requiring new capital investment in facilities. This represents an exceptionally efficient approach to healthcare resource allocation while potentially reducing geographic disparities in cancer care quality.
This FDA approval introduces significant technical advancements in PSMA-PET imaging that address key operational constraints that have widespread adoption. The extended shelf life of up to six hours represents a breakthrough in radiopharmaceutical stability for gallium-based agents, which typically degrade rapidly after production.
The clinical implications are substantial. With conventional gallium PSMA agents, imaging centers operate under extremely tight scheduling constraints, creating workflow bottlenecks and patient access limitations. The extended stability of Gozellix® enables more flexible scheduling protocols, potentially increasing patient throughput and scanner utilization efficiency.
Of equal importance is the expanded distribution radius, which effectively enlarges the serviceable geography for each production site. This directly addresses the "radiopharmacy desert" problem where facilities located beyond critical distance thresholds from radiopharmaceutical production sites simply cannot offer PSMA-PET imaging regardless of demand.
The dual-product strategy of maintaining both Gozellix® and Illuccix® demonstrates sophisticated market segmentation. Certain high-volume urban centers may prioritize the established workflow, while facilities previously unable to participate in PSMA imaging can now incorporate these diagnostics into their practice.
For patients, the improved logistics translate to earlier access to diagnostic information that guides treatment selection and planning. With PSMA-PET's superior sensitivity in detecting small metastases compared to conventional imaging, this expanded access could meaningfully impact treatment decisions and patient outcomes.
MELBOURNE, Australia and INDIANAPOLIS, March 21, 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 its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging1 agent for prostate cancer.
Gozellix®, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Gozellix® is a novel product which provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products. The ability to reliably deliver the product much further from its point of production means Gozellix® can reach PET cameras that are currently not served by any PSMA imaging providers, bringing the accuracy and clinical utility of gallium-based imaging to more patients across the U.S. The innovative formulation, which allows for more scalable production, also has the potential to enhance the efficiency, scheduling flexibility and throughput of scanning clinics.
Gozellix® builds on the success of Telix’s established PSMA-PET imaging agent, Illuccix®, and will be available alongside the first-generation product, providing choice for customers and patients based on their individual needs.
In the U.S., the accuracy and sensitivity of PSMA-PET imaging means it has become the standard of care for prostate cancer imaging after initial diagnosis and biochemical recurrence2. However, only a relatively small fraction of the 3.4 million men living with prostate cancer in the U.S. have undergone this type of precision medicine scan3,4. Telix believes Gozellix® will help to address these access issues, as it is expected to be eligible for full reimbursement5 with reduced or no patient co-insurance, meaning it can reach more patients, particularly in underserved populations.
Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, “Securing FDA approval for Gozellix is a major win for prostate cancer patients, who gain enhanced access to state-of-the-art 68Ga PSMA-PET imaging. Telix continues to invest in innovation across our portfolio, and Gozellix is a testament to this continuous improvement approach. With the launch of Gozellix, our team is excited to be bringing the new generation of prostate cancer scanning to more American men, delivered with the reliability, service and flexibility that customers have come to expect from Telix.”
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Risk for Misinterpretation
Image interpretation errors can occur with GOZELLIX 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 GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX 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.
Hypersensitivity Reactions to Sulfites
Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
ADVERSE REACTIONS
The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR 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 <
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 Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.
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, 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. 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, has been approved by the U.S. FDA6, by the Australian Therapeutic Goods Administration (TGA)7, by Health Canada8, by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)9, by the Brazilian Health Regulatory Agency (ANVISA)10, and in multiple countries within the European Economic Area (EEA)11 following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM12. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA13.
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.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
Legal Notices
You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.
The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.
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©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country.
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1 Imaging of prostate-specific membrane antigen with positron emission tomography.
2 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2024.
3 NIH Common Cancer Sites — Cancer Stat Facts. Accessed May 2024.
4 Company analysis based on proprietary and public domain data.
5 Hospital Outpatient Prospective Payment System (OPPS) patients eligible for reimbursed PSMA-PET scanning.
6 Telix ASX disclosure 20 December 2021.
7 Telix ASX disclosure 2 November 2021
8 Telix ASX disclosure 14 October 2022.
9 Telix ASX disclosure 13 February 2025.
10 Telix ASX disclosure 18 March 2025.
11 Denmark, Luxembourg, Malta, the Netherlands and Norway at time of release.
12 Telix ASX disclosure 17 January 2025.
13 Telix ASX disclosure 21 March 2025.
FAQ
What are the key advantages of Telix's new Gozellix® (TLX) over existing PSMA-PET imaging agents?
How will the FDA approval of Gozellix® impact prostate cancer patient access to PSMA-PET imaging?
What is the specific indication for Gozellix® (TLX) in prostate cancer imaging?
What are the most common adverse reactions reported in Gozellix® clinical trials?
How many patients were evaluated in the safety studies for Gozellix® (TLX)?
