FDA has accepted Telix Pharmaceuticals’ submission of a New Drug Application (NDA) for TLX007-CDx, a novel cold kit for the preparation of PSMA-PET imaging in prostate cancer patients.
TLX007-CDX marks a potential advancement in prostate cancer diagnosis and management.
Dr. Christian Behrenbruch, Managing Director and Group CEO of Telix, acknowledged the FDA’s acceptance of the filing for TLX007-CDx.The rapid adoption and geographic expansion of PSMA-PET imaging with Illuccix® offered a promising advancement in prostate cancer care.
He emphasized TLX007-CDX as an essential step towards improving equity of access and reinforcing a commitment to innovation.
The focus remained on meeting the needs of healthcare professionals and prostate cancer patients, particularly in underserved communities and regions with limited access to state-of-the-art imaging.
The next phase involves working with the FDA to make TLX007-CDx available to American men living with prostate cancer.
If approved, TLX007-CDx could expand access to PSMA-PET imaging, a standard of care surpassing traditional imaging methods, to a larger prostate cancer patient population.
Telix emphasized the potential to improve patient outcomes through increased availability of TLX007-CDX critical diagnostic tools.
Source: FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent
https://telixpharma.com/news-views/fda-accepts-telix-nda-for-new-prostate-imaging-agent/
