The FDA has accepted the submitting of a brand new drug utility (NDA) searching for approval of TLX007-CDx, an investigational chilly package for the preparation of PSMA-PET imaging for prostate most cancers, Telix Prescription drugs introduced in a information launch.1
The NDA for TLX007-CDx was submitted in Might 2024.
The FDA should decide concerning the NDA on or by the PDUFA objective date of March 24, 2025.
“We now have seen fast adoption and geographic enlargement of PSMA-PET imaging with our first business product Illuccix. This submitting acceptance is a crucial step in direction of additional bettering fairness of entry and reinforcing our dedication to innovation in prostate most cancers to proceed to fulfill the wants of well being care professionals and their sufferers,” mentioned Christian Behrenbruch, DPhil, MBA, JD, managing director and group CEO of Telix Prescription drugs, within the information launch.1 “We now look ahead to 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.”
The NDA for TLX007-CDx was submitted in Might 2024. With a possible approval for the agent, Telix hopes to broaden entry to PSMA-PET imaging throughout the US.
TLX007-CDx makes use of “68Ga sourced from each newer excessive exercise turbines and cyclotrons powered by the ARTMS QUANTM Irradiation System and GE FASTlab stable and liquid goal manufacturing system,” in accordance with Telix.1 Telix lately introduced the acquisition of ARTMS in March 2024.2 The chilly package can also allow use of a PSMA imaging product with an prolonged distribution profile in contrast with presently authorised gallium-68 (68Ga) PSMA-PET imaging brokers, in accordance with the corporate.
An approval for TLX007-CDx would broaden Telix’s imaging portfolio.
In December 2021, Telix obtained FDA approval for 68Ga-PSMA-11 (Illuccix), a package for the preparation of gallium Ga 68 gozetotide injection in sufferers with prostate most cancers with suspected metastasis who’re candidates for preliminary definitive remedy and for sufferers with suspected recurrence primarily based on elevated serum PSA.3 An expanded indication of Illuccix was authorised in March 2023 to incorporate sufferers with metastatic prostate most cancers who’re indicated for 177Lu 177 PSMA-directed remedy.4 68Ga-PSMA-11 has additionally obtained approval in Canada and Australia.
References
1. FDA accepts Telix NDA for brand new prostate most cancers imaging agent. Information launch. Telix Prescription drugs Restricted. July 23, 2024. Accessed July 24, 2024. https://www.globenewswire.com/en/news-release/2024/07/23/2917666/0/en/FDA-Accepts-Telix-NDA-for-New-Prostate-Most cancers-Imaging-Agent.html
2 Telix to amass ARTMS, Inc. and its superior isotope manufacturing platform. Information launch. March 5, 2024. Accessed July 24, 2024. https://telixpharma.com/news-views/telix-to-acquire-artms-inc-and-its-advanced-isotope-production-platform/
3. FDA approves Telix’s prostate most cancers imaging product, Illuccix. Information launch. December 20, 2021. Accessed July 24, 2024. https://telixpharma.com/news-views/fda-approves-telixs-prostate-cancer-imaging-product-illuccix/
4. FDA approves expanded indication for Telix’s Illuccix to incorporate affected person choice for PSMA-directed radioligand remedy. Information launch. March 16, 2023. Accessed July 24, 2024. https://telixpharma.com/news-views/fda-approves-expanded-indication-for-telixs-illuccix-to-include-patient-selection-for-psma-directed-radioligand-therapy/
