Approval sought for TLX007-CDx in prostate cancer

Telix Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for approval of TLX007-CDx, a cold kit for the preparation of PSMA-PET imaging for prostate cancer, the company announced in a news release.¹

"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," says Christian Behrenbruch, PhD, MBA, JD.

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 the news release.¹ Telix recently announced the acquisition of ARTMS in March 2024.² The cold kitmay 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, access to PSMA-PET imaging remains limited across the United States (US), especially for Black patients and Veterans, who already experience higher rates of prostate cancer compared with the general population. With TLX007-CDx, Telix hopes to expand access to PSMA-PET imaging across the US.

“Even in some of the most populous US states, access to PSMA-PET imaging can be highly variable. Patients in rural areas of the country often bear the extra burden of long-distance travel, extended time off work, and increased out of pocket costs to access medical services. All of these factors contribute to ‘financial toxicity’ as well as challenges in accessing proper care commonly associated with cancer treatment,” said Mike Crosby, Founder and CEO of Veterans Prostate Cancer Awareness, in the news release.¹ “If approved by the FDA, this new product will have a significant impact on prostate cancer patients, physicians, and their caregivers by helping to eliminate the inequity of access to PSMA-PET agents, and increase the ability to accurately diagnose cancer early, reducing the cost of care, and increasing the probability of patients’ survival.”

Approval of TLX007-CDx would also 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 68Ga-PSMA-11 has also received approval in Canada and Australia.

“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,” concluded Christian Behrenbruch, PhD, MBA, JD, Managing Director and Group CEO of Telix, in the news release.¹ “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.”

References

1. Telix submits NDA for new prostate cancer imaging agent. News release. Telix. May 27, 2024. Accessed May 28, 2024. https://telixpharma.com/news-views/telix-submits-nda-for-new-prostate-cancer-imaging-agent/

2 Telix to acquire ARTMS, Inc. and its advanced isotope production platform. News release. March 5, 2024. Accessed March 28, 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 May 28, 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 May 28, 2024. https://telixpharma.com/news-views/fda-approves-expanded-indication-for-telixs-illuccix-to-include-patient-selection-for-psma-directed-radioligand-therapy/