Telix' NDA For TLX007-CDx Accepted By FDA For Prostate Cancer Imaging

(RTTNews) - Telix Pharmaceuticals Limited (TLX.AX) said that the U.S. Food and Drug Administration has accepted the filing of its New Drug Application (NDA) for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer. The Prescription Drug User Fee Act (PDUFA) goal date is March 24, 2025.

If approved, the new Kit will enable use of a PSMA imaging product with a considerably extended geographic distribution radius from a nuclear pharmacy compared to currently approved gallium-68 based agents, the company said.

PSMA-PET imaging represents a major advancement in prostate cancer management and in the U.S. has replaced conventional imaging methods (bone scan, CT scan) as the standard of care after initial diagnosis and biochemical recurrence.