FDA approves new drug application for Telix’s brain cancer imaging agent

The news: The US Food and Drug Administration (FDA) has accepted Telix Pharmaceuticals’ resubmitted new drug application (NDA) for its progressive glioma (brain cancer) imaging agent TLX101-Px.

The context: Telix said the approval of TLX101-Px will fulfil a significant unmet medical need for the characterisation of recurrent or progressive glioma from treatment-related changes in both adult and paediatric patients.

What they said: “The FDA’s acceptance of our NDA resubmission is an important milestone for Telix,” said Kevin Richardson, the company’s CEO for precision medicine.

“We appreciate the FDA’s constructive engagement and look forward to working closely with the agency to urgently obtain approval and then bring this product to market for the benefit of patients.”