July 24, 2024 — Telix Prescribed drugs Restricted introduced that the USA (U.S.) Meals and Drug Administration (FDA) has accepted the submitting of its New Drug Software (NDA) for TLX007-CDx, a brand new and proprietary chilly equipment (“Equipment”) for the preparation of PSMA-PET imaging[1] for prostate most cancers. The PDUFA[2] aim 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 present permitted gallium-68 (68Ga) based mostly brokers. Its progressive properties are designed to facilitate extra versatile manufacturing, together with with larger exercise 68Ga sourced from each newer excessive exercise turbines and cyclotrons powered by the ARTMSQUANTM Irradiation System[3] and GE FASTlab [4] stable and liquid goal manufacturing system. Via this NDA, Telix’s goal is to additional improve affected person entry to PSMA-PET imaging and the medical 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 standard imaging strategies (bone scan, CT scan) as the usual of care after preliminary prognosis and biochemical recurrence[5]. 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 scan[6],[7].
Dr Christian Behrenbruch, Managing Director and Group CEO of Telix acknowledged, “Now we have seen speedy adoption and geographic enlargement of PSMA-PET imaging with our first industrial product Illuccix. This submitting acceptance is a crucial step in direction of additional enhancing fairness of entry and reinforcing our dedication to innovation in prostate most cancers to proceed to fulfill the wants of healthcare professionals and their sufferers. We now stay up for working with the FDA to deliver 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.”
For extra data: www.telixpharma.com
References:
[1] Imaging of prostate-specific membrane antigen with positron emission tomography.
[2] Prescription Drug Consumer Charge Act.
[3] Telix ASX disclosure 11 April 2024. For additional data go to: https://www.artms.ca/
[4] FASTlab is a trademark of GE Healthcare and its associates.
[5] NCCN Medical Observe Pointers in Oncology (NCCN Pointers®) for Prostate Most cancers V.4.2024.
[6] NIH Widespread Most cancers Websites — Most cancers Stat Info. Accessed Could 2024.
[7] Firm evaluation based mostly on proprietary and public area information.
[8] Telix ASX disclosure 20 December 2021.
[9] Telix ASX disclosure 2 November 2021.
[10] Telix ASX disclosure 14 October 2022.
