FDA Accepts NDA of TLX007-CDx in Prostate Cancer

• The FDA accepted the filing of a new drug application (NDA) for TLX007-CDx.
• TLX007-CDx is a new and proprietary cold kit for the preparation of prostate-specific membrane antigen (PSMA)-PET imaging for prostate cancer.
• The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 24, 2025.

The NDA for TLX007-CDx has been accepted by the FDA for the preparation of PSMA-PET imaging for prostate cancer. A PDUFA goal date of March 24, 2025, has been set.¹

TLX007-CDx is a cold kit for the preparation of PSMA-PET imaging for prostate cancer. TLX007-CDx utilizes gallium-68 (⁶⁸Ga) that is sourced from newer high activity generators as well as cyclotrons that are powered by the ARTMS QUANTM Irradiation System and GE FASTlab solid and liquid target production system.

If approved by the FDA, the cold kit may enable the use of a PSMA imaging product with an extended distribution profile compared with the currently approved ⁶⁸Ga PSMA-PET imaging agents.

Prostate cancer under the microscope: © heitipaves - stock.adobe.com

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

With the NDA, the company plans to continue to advance patient access to PSMA-PET imaging. It also aims to enhance the clinical benefits of ⁶⁸Ga imaging to patient populations that are underserved across the US through the use of nuclear pharmacy distribution partnerships and industry-leading on-time reliability established by Telix.

Currently, TLX007-CDx has not received marketing authorization in any jurisdiction.

Previously in December 2021, ⁶⁸Ga-PSMA-11 (Illuccix) was granted approval by the FDA.² This kit is for the preparation of 68Ga gozetotide injection in patients with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy. This approval is also intended for patients with suspected recurrence based on elevated serum prostate-specific antigen.

In March 2023, the FDA expanded the indication of 68Ga-PSMA-11 to include patients with metastatic prostate cancer indicated for ¹⁷⁷Lu 177 PSMA-directed therapy.³ Further, ⁶⁸Ga-PSMA-11 is approved in Canada and Australia.

REFERENCES:

1. FDA accepts Telix NDA for new prostate cancer imaging agent. News release. Telix. July 24, 2024. Accessed July 24, 2024. https://tinyurl.com/pd4ktnn2

2. FDA approves Telix’s prostate cancer imaging product, Illuccix. News release. December 20, 2021. Accessed July 24, 2024. https://tinyurl.com/55swyyz8

3. 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://tinyurl.com/3edj3nb9