Telix Pharmaceuticals (ASX:TLX) said Friday its marketing authorization application filed in Europe for TLX101-Px, its glioma imaging candidate, has been validated and accepted for review, moving into a 210-day active assessment phase.
In a statement, the company said it is seeking a broad clinical label, reflective of current clinical practice guidelines, with national marketing authorizations expected to follow shortly after a positive outcome at day 210.
The company said it aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications.
TLX101-Px is also being developed as a patient selection and response assessment tool for Telix's glioblastoma therapy candidate TLX101-Tx, which has been granted orphan drug designation in Europe and the US, per the statement.
The phase 3 IPAX-BrIGHT trial of TLX101-Tx in patients with recurrent glioblastoma has started patient dosing internationally and is launching in multiple European countries, the company said.
Telix Pharmaceuticals' shares were up 3% in recent Friday trade.