FDA Accepts the New Drug Application for TLX007-CDx Kit in Prostate Cancer

The FDA has accepted the new drug application (NDA) for the proprietary cold kit TLX007-CDx for the preparation of prostate-specific membrane antigen positron emission tomography (PSMA-PET) imaging in patients with prostate cancer. The Prescription Drug User Fee Act goal date is March 24, 2025.¹

TLX007-CDx uses higher activity Gallium 68 (68Ga) sourced from newer high activity generators and cyclotrons powered by the ARTMS QUANTM Irradiation System and GE FASTlab solid and liquid target production system. If approved, TLX007-CDx will allow for the use of a PSMA imaging product with a significantly extended geographic distribution radius from a nuclear pharmacy compared with available 68Ga-based agents. The objective of the NDA is to enhance patient access to PSMA-PET imaging and expand the clinical benefits of 68Ga to underserved populations in the US.

“We have seen rapid adoption and geographic expansion of PSMA-PET imaging with our first commercial product Illuccix,” Christian Behrenbruch PhD, MBA, managing director and group CEO of Telix, said in a press release.¹ “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. 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.”

PSMA-PET imaging has replaced conventional imaging methods for patients with prostate cancer in the US, such as bone and CT scan, as the standard of care following initial diagnosis and biochemical recurrence. However, only a small percentage of the approximately 3.4 million patients with prostate cancer in the US have undergone a scan with the imaging modality.

68Ga gozetotide injection (68Ga-PSMA-11; Illuccix) was approved by the FDA in December 2021, making it the first commercially available FDA-approved product to enable wide accessibility to 68Ga-based PSMA-PET imaging for patients with prostate cancer in the US. The product is indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen level. The agent is also approved by the Australian Therapeutic Goods Administration and Health Canada.^1,2

In March 2023, the FDA approved a supplementary NDA for 68Ga-PSMA-11 to expand its indication to include patients with metastatic prostate cancer, for whom Lutetium 177 (177Lu) PSMA-directed therapy is indicated.3

No other Telix products have received a marketing authorization in any jurisdiction worldwide.¹

References

1. FDA Accepts Telix NDA for new prostate cancer imaging agent. News release. Telix Pharmaceuticals Limited. July 24, 2024. Accessed July 24, 2024. https://www.prnewswire.com/apac/news-releases/fda-accepts-telix-nda-for-new-prostate-cancer-imaging-agent-302204667.html
2. FDA approves Telix’s prostate cancer imaging product, Illuccix. News release. Telix Pharmaceuticals Limited. December 20, 2021. Accessed July 24, 2024. https://telixpharma.com/news-views/fda-approves-telixs-prostate-cancer-imaging-product-illuccix/
3. FDA approves expanded indication for Telix’s Illuccix to include patient selection for PSMA-directed radioligand therapy. News release. Telix Pharmaceuticals Limited. 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/