Telix Pharmaceuticals (ASX:TLX) has filed a new drug application with the US FDA for its radiopharmaceutical targeting ProstateSpecific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET).
The company is seeking an indication for the diagnostic imaging of prostate cancer for its TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11), including from the early pre-treatment setting through to the later stages of advanced disease.
The company has requested the application be considered for priority review.
According to chief medical officer, Dr Colin Hayward, “The use of 68Ga-PSMA PET imaging is rapidly becoming the standard of care for prostate cancer imaging across a broad range of clinical settings. PSMA imaging is already included in the leading clinical practice guidelines in the United States and Europe, based on evidence that definitively demonstrates superiority over conventional imaging. This is highly supportive of rapid adoption of Telix’s product upon approval.”
Telix CEO, Dr Christian Behrenbruch, said, “We are delighted to have achieved this significant milestone with the FDA’s acceptance for filing of the first commercial NDA for PSMA imaging in the United States. This represents a major step towards our goal of providing this highly anticipated product to patients in the United States and beyond. From acquiring ANMI 4 and its advanced chemistry platform in December 2018, to successfully filing an NDA less than two years later, represents an extraordinary achievement by the Telix team. We now look forward to working with the FDA to bring TLX591-CDx to American patients living with prostate cancer as expeditiously as possible.”
Telix said its application to the FDA includes clinical data from over 600 patients obtained from studies performed by it or in collaboration with research partners.