NDA Submitted for Prostate Cancer Companion Diagnostic, TLX591-CDx

Telix Pharmaceuticals announced it has submitted a new drug application (NDA) to the FDA for TLX591-CDx (illumet), a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) intended for the imaging of prostate cancer using positron emission tomography (PET).¹

The NDA submission of the companion diagnostic includes clinical data from more than 600 patients obtained from both prospective and retrospective clinical studies performed either by Telix or in collaboration. In addition, the submission builds on definitive peer-reviewed clinical research conducted at leading academic centers including the University of California in Los Angeles, California, the Peter MacCallum Cancer Centre in Australia, and Heidelberg University Hospital in Germany.

“We are pleased to have achieved this significant milestone with the submission of the first commercial NDA for PSMA imaging in the United States. Telix has engaged with the FDA since July 2019, with valuable guidance resulting in what we believe to be a comprehensive submission,” Bernard Lambert, PhD, US president of Telix, said in a press release. “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 the swift preparation of 68Ga-PSMA-11 injection, enabling rapid radiolabeling at room temperature with high radiochemical purity and production consistency. Moreover, it is compatible with the 68Ga generators that are already commercially available.²

References:

1. Telix Pharmaceuticals Submits New Drug Application to US FDA for Prostate Cancer Imaging Product [news release]. Melbourne, Australia and Indianapolis. Published September 24, 2020. Accessed September 28, 2020. https://www.globenewswire.com/news-release/2020/09/23/2098375/0/en/Telix-Pharmaceuticals-Submits-New-Drug-Application-to-US-FDA-for-Prostate-Cancer-Imaging-Product.html

2. Telix Pharmaceuticals. TLX591 PROSTATE CANCER. Telix Pharmaceuticals website. Published 2020. Accessed September 28, 2020. https://telixpharma.com/pipeline/tlx591/