Australian company Telix Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for TLX007-CDx, a new prostate cancer imaging kit.
This kit will be used for the preparation of prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging for prostate cancer diagnosis and management.
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It is subject to regulatory approval and expected to have extended distribution profile compared to PSMA imaging products that are currently approved with gallium-68 (68Ga) PSMA-PET imaging agents.
The kit’s properties allow for more flexible production, including with 68Ga sourced from newer high activity generators as well as cyclotrons powered by the ARTMS QUANTM Irradiation System and GE FASTlab production system.
The company aims to improve the availability and scheduling flexibility of PSMA-PET imaging across the healthcare system.
Despite the availability of PSMA-PET imaging agents in the US, access remains limited, particularly affecting African Americans and Veterans.
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By GlobalDataThese groups suffer from higher incidence rates of prostate cancer, often presenting at advanced stages.
Telix’s investigational product seeks to address these disparities and enhance access through nuclear pharmacy distribution partnerships.
Telix managing director and group CEO Dr Christian Behrenbruch said: “The scheduling flexibility and accessibility, along with the excellent clinical performance of 68Ga-based PSMA-PET imaging, has enabled Telix to drive rapid geographic expansion of PSMA-PET imaging with our first product Illuccix.
“A core value of our company is the commitment to improving access to medicine and delivering clinical utility that will benefit patients, very much reflected in the development of this exciting new product. We believe this is particularly important as demand for PSMA-PET imaging is forecast to grow significantly over the coming decade.”
PSMA-PET imaging is an advancement in prostate cancer care, that can replace traditional imaging methods as the standard of care post-diagnosis and during biochemical recurrence.
In December, the company submitted a biologics license application (BLA) to the FDA for Zircaix (TLX250-CDx).
