MELBOURNE, Australia and INDIANAPOLIS, IN, USA I December 30, 2024 I Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®1, 89Zr- girentuximab) kidney cancer imaging2.
TLX250-CDx is an investigational PET3 drug product for the non-invasive diagnosis and characterization of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S., further building on Telix’s successful urology imaging franchise.
The FDA is expected to advise the PDUFA4 goal date following the 60-day administrative review of the application.
Kevin Richardson, Chief Executive Officer, Precision Medicine at Telix, stated, “We are pleased to be progressing the BLA for TLX250-CDx, which has been granted Breakthrough designation, and may therefore be eligible for priority review. Telix continues to target a full U.S. commercial launch in 2025 addressing a major unmet medical need for patients with suspected ccRCC.”
About TLX250-CDx
TLX250-CDx (Zircaix®1) is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent radiology readers5. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of diagnostic and therapeutic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, 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).
Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)6, by the Australian Therapeutic Goods Administration (TGA) 7, and by Health Canada8. No other Telix product has received a marketing authorization in any jurisdiction.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.
1 Brand name subject to final regulatory approval.
2 Telix ASX disclosure 31 July 2024. The FDA requested additional data demonstrating adequate sterility assurance during dispensing of TLX250-CDx in the radiopharmacy production environment.
3 Positron emission tomography.
4 Prescription Drug User Fee Act.
5 Shuch et al. Lancet Oncol. 2024. Telix ASX disclosures 7 November 2022.
6 Telix ASX disclosure 20 December 2021.
7 Telix ASX disclosure 2 November 2021.
8 Telix ASX disclosure 14 October 2022.
SOURCE: Telix Pharmaceuticals
Post Views: 359
MELBOURNE, Australia and INDIANAPOLIS, IN, USA I December 30, 2024 I Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®1, 89Zr- girentuximab) kidney cancer imaging2.
TLX250-CDx is an investigational PET3 drug product for the non-invasive diagnosis and characterization of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S., further building on Telix’s successful urology imaging franchise.
The FDA is expected to advise the PDUFA4 goal date following the 60-day administrative review of the application.
Kevin Richardson, Chief Executive Officer, Precision Medicine at Telix, stated, “We are pleased to be progressing the BLA for TLX250-CDx, which has been granted Breakthrough designation, and may therefore be eligible for priority review. Telix continues to target a full U.S. commercial launch in 2025 addressing a major unmet medical need for patients with suspected ccRCC.”
About TLX250-CDx
TLX250-CDx (Zircaix®1) is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent radiology readers5. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of diagnostic and therapeutic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, 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).
Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)6, by the Australian Therapeutic Goods Administration (TGA) 7, and by Health Canada8. No other Telix product has received a marketing authorization in any jurisdiction.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.
1 Brand name subject to final regulatory approval.
2 Telix ASX disclosure 31 July 2024. The FDA requested additional data demonstrating adequate sterility assurance during dispensing of TLX250-CDx in the radiopharmacy production environment.
3 Positron emission tomography.
4 Prescription Drug User Fee Act.
5 Shuch et al. Lancet Oncol. 2024. Telix ASX disclosures 7 November 2022.
6 Telix ASX disclosure 20 December 2021.
7 Telix ASX disclosure 2 November 2021.
8 Telix ASX disclosure 14 October 2022.
SOURCE: Telix Pharmaceuticals
Post Views: 359
