Telix Pharmaceuticals (ASX:TLX) has submitted a New Drug Application (NDA) to the US FDA for TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11), a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET).
Telix said its NDA submission for TLX591-CDx includes clinical data from over 600 patients obtained from both prospective and retrospective clinical studies performed by the company or in collaboration.
It said the submission also builds on definitive peer-reviewed clinical research conducted at academic centres including the University of California, Los Angeles, the Peter MacCallum Cancer Centre in Melbourne and Heidelberg University Hospital in Germany.
Telix US president Dr Bernard Lambert said, “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. 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.”
Telix CEO Dr Christian Behrenbruch added, “Submitting an NDA to the US Food and Drug Administration for our first product is a major commercial inflection point for the Company and follows our European submission earlier this year. The Telix team and our advisors have done an outstanding job of preparing this submission, which we believe is founded on compelling clinical evidence that supports broad diagnostic utility in the management of prostate cancer. I’d like to acknowledge the commitment of our investigators, study teams and the independent physician readers who contributed to our clinical data package.”
Telix said it would like to "gratefully acknowledge"e Eckert & Ziegler AG, IRE ELiT and GE Healthcare, who collaborated with it to validate both 68Ge/68Ga generator and cyclotron-based 68Ga production systems with TLX591-CDx for the NDA submission.
It added, "The Company wishes to particularly acknowledge and thank Memorial Sloan Kettering Cancer Center (MSKCC) and Advanced Accelerator Applications (a Novartis Company) for their significant contribution to the NDA submission and their commitment to men’s health."