Telix Pharmaceuticals resubmits brain cancer imaging application to the FDA
Make us a preferred source
Make us a preferred source on Google
The news: Telix Pharmaceuticals has resubmitted the requested new drug application (NDA) for its progressive glioma (brain cancer) imaging, TLX101-pX, to the US Food and Drug Administration (FDA).
The context: This follows the company’s market authorisation application in Europe last month, which aims to provide European patients with clarity in their brain cancer diagnosis and treatment.
The NDA resubmission follows further data requested by the FDA, including additional statistical analysis and primary data set provided in the original submission.
Telix said, due to significant unmet medical needs and the urgent nature of the trial, TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA.
What they said: “Our resubmission is supported by an extensive and compelling data set, particularly so for an orphan indicator. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the US can benefit from this important patient management tool,” Telix Group chief medical officer David Cade said.
The source: ASX
