TLX007-CDx under FDA review for approval in prostate cancer

The FDA has accepted the filing of a new drug application (NDA) seeking approval of TLX007-CDx, an investigational cold kit for the preparation of PSMA-PET imaging for prostate cancer, Telix Pharmaceuticals announced in a news release.¹

The NDA for TLX007-CDx was submitted in May 2024.

The FDA must make a decision regarding the NDA on or by the PDUFA goal date of March 24, 2025.

“We have seen rapid adoption and geographic expansion of PSMA-PET imaging with our first commercial product Illuccix. This filing acceptance is an important step towards further improving equity of access and reinforcing our commitment to innovation in prostate cancer to continue to meet the needs of health care professionals and their patients,” said Christian Behrenbruch, DPhil, MBA, JD, managing director and group CEO of Telix Pharmaceuticals, in the news release.¹ “We now look forward to working with the FDA to bring TLX007-CDx to American men living with prostate cancer, including those residing in underserved communities and regions where access to state-of-the art imaging remains limited.”

The NDA for TLX007-CDx was submitted in May 2024. With a potential approval for the agent, Telix hopes to expand access to PSMA-PET imaging across the US.

TLX007-CDx utilizes “⁶⁸Ga sourced from both newer high activity generators and cyclotrons powered by the ARTMS QUANTM Irradiation System and GE FASTlab solid and liquid target production system,” according to Telix.¹ Telix recently announced the acquisition of ARTMS in March 2024.2 The cold kit may also enable use of a PSMA imaging product with an extended distribution profile compared with currently approved gallium-68 (68Ga) PSMA-PET imaging agents, according to the company.

An approval for TLX007-CDx would expand Telix’s imaging portfolio.

In December 2021, Telix received FDA approval for 68Ga-PSMA-11 (Illuccix), a kit for the preparation of gallium Ga 68 gozetotide injection in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and for patients with suspected recurrence based on elevated serum PSA.³ An expanded indication of Illuccix was approved in March 2023 to include patients with metastatic prostate cancer who are indicated for ¹⁷⁷Lu 177 PSMA-directed therapy.^{4 68}Ga-PSMA-11 has also received approval in Canada and Australia.

References

1. FDA accepts Telix NDA for new prostate cancer imaging agent. News release. Telix Pharmaceuticals Limited. 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-Cancer-Imaging-Agent.html

2 Telix to acquire ARTMS, Inc. and its advanced isotope production platform. News release. 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 cancer imaging product, Illuccix. News release. 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 include patient selection for PSMA-directed radioligand therapy. News release. 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/