Posted: 29 July 2024
Telix in the present day pronounces that the US (U.S.) Meals and Drug Administration (FDA) has accepted the submitting of its New Drug Utility (NDA) for TLX007-CDx, a brand new and proprietary chilly package (“Equipment”) for the preparation of PSMA-PET imaging1 for prostate most cancers. The PDUFA2 purpose date is March 24, 2025.
If permitted, the brand new Equipment will allow use of a PSMA imaging product with a significantly prolonged geographic distribution radius from a nuclear pharmacy in comparison with at the moment permitted gallium-68 (68Ga) based mostly brokers. Its revolutionary properties are designed to facilitate extra versatile manufacturing, together with with increased exercise 68Ga sourced from each newer excessive exercise mills and cyclotrons powered by the ARTMS® QUANTM Irradiation System™3 and GE FASTlab™4 strong and liquid goal manufacturing system. By this NDA, Telix’s goal is to additional improve affected person entry to PSMA-PET imaging and the scientific advantages of 68Ga imaging to underserved populations throughout the U.S., utilizing Telix’s established nuclear pharmacy distribution partnerships and industry-leading on-time reliability.
PSMA-PET imaging represents a significant development in prostate most cancers administration and within the U.S. has changed typical imaging strategies (bone scan, CT scan) as the usual of care after preliminary analysis and biochemical recurrence5. Regardless of this main medical development, solely a comparatively small fraction of the three.4 million males residing with prostate most cancers in America have undergone a PSMA-PET imaging scan6.
Dr Christian Behrenbruch, Managing Director and Group CEO of Telix said, “We now have seen speedy adoption and geographic growth of PSMA-PET imaging with our first industrial product Illuccix®, and this submitting acceptance is a crucial step in the direction of additional bettering fairness of entry and reinforcing our dedication to innovation in prostate most cancers to proceed to satisfy the wants of healthcare professionals and their sufferers. We now sit up for working with the FDA to convey TLX007-CDx to American males residing with prostate most cancers, together with these residing in underserved communities and areas the place entry to state-of-the artwork imaging stays restricted.”
