NDA Filed for Prostate-specific Membrane Antigen Imaging Product

A new drug application (NDA) has been submitted to the FDA for TLX591-CDx (illumet), a radiopharmaceutical product that targets prostate-specific membrane antigen (PSMA), for the imaging of prostate cancer through the use of positron emission tomography, according to an announcement from Telix Pharmaceuticals Limited.¹ The application for the product is comprised of clinical findings collected from over 600 patients who participated in prospective and retrospective clinical trials that were conducted by Telix Pharmaceuticals or in collaboration.

The NDA is also based on definitive peer-reviewed clinical research that had been conducted at the University of California, Los Angeles (UCLA), the Peter MacCallum Cancer Centre, and Heidelberg University Hospital.

“We are pleased to have achieved this significant milestone with the submission of the first commercial NDA for PSMA imaging in the United States,” Bernard Lambert, MD, president of Telix Pharmaceuticals USA, stated in a press release. “Telix has engaged with the FDA since July 2019, with valuable guidance resulting in what we believe to be a comprehensive submission. Subject to FDA approval, we look forward to bringing this product to market with our commercial partners to serve the needs of men living with prostate cancer.”

TLX591-CDx is a radiopharmaceutical for the imaging of metastatic prostate cancer. The imaging product comes in a “cold kit” to allow for quick preparation of 68Ga-PSMA-11 injection, rapid radiolabeling at room temperature with high radiochemical purity; it is compatible with the 68Ga generators that are already commercially available.²

Click to continue reading on OncLive.