NEW YORK – Telix Pharmaceuticals on Tuesday said it has filed for US Food and Drug Administration approval for TLX007-CDx, a radiopharmaceutical imaging agent for identifying patients with prostate-specific membrane antigen (PSMA)-positive prostate cancer.
The FDA has accepted Telix's new drug application and expects to decide on whether to approve it by March 24, 2025.
According to Melbourne, Australia-based Telix, TLX007-CDx involves a more flexible production process than other radiopharmaceutical imaging agents, in part because it will involve sourcing the isotope gallium-68 from new, high-activity generators and cyclotrons. The imaging agent uses the radioactive isotope gallium-68 linked to a PSMA-targeting agent. This could allow more nuclear pharmacies to provide TLX007-CDx, which Telix hopes will improve patients' access to PSMA-PET imaging.
"We now look forward to working with the FDA to bring TLX007-CDx to American men living with prostate cancer, including those residing in underserved communities and regions where access to state-of-the-art imaging remains limited," Christian Behrenbruch, managing director and group CEO at Telix, said in a statement.
Telix already markets a gallium-based imaging agent, Illuccix (Ga-68 PSMA-11), as a companion diagnostic for identifying metastatic castration-resistant prostate cancer (mCRPC) patients eligible for Novartis' radiopharmaceutical Pluvicto (lutetium vipivotide tetraxetan). Telix said it is aiming to improve on Illuccix's imaging capabilities with TLX007-CDx.