FDA Accepts New Drug Application for Prostate Cancer Imaging Agent

The United States Food and Drug Administration (FDA) has accepted Telix Pharmaceuticals Limited’s filing of a New Drug Application (NDA) for TLX007-CDx–a proprietary cold kit (“Kit”) for the preparation of prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging for prostate cancer.

“We have seen rapid adoption and geographic expansion of PSMA-PET imaging with our first commercial product Illuccix,” said Dr. Christian Behrenbruch, managing director and group chief executive officer of Telix, in a press release. “This filing acceptance is an important step toward 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.”

While PSMA-PET imaging has surpassed conventional imaging methods such as bone and computed tomography scans as the standard of care after initial prostate cancer diagnosis and biochemical recurrence, only a small percentage of patients with prostate cancer in the United States have undergone a PSMA-PET imaging scan.

If granted FDA approval, the Kit will enable use of a PSMA imaging product with a “considerably extended geographic distribution radius from a nuclear pharmacy” compared with available gallium-68 (⁶⁸Ga) agents. With this NDA, Telix hopes to increase patient access to PSMA-PET imaging and ⁶⁸Ga imaging to underserved populations throughout the United States.

“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,” Dr. Behrenbruch added.