Australian company Telix Pharmaceuticals (ASX:TLX) has announced the Ministry of Health of the Czech Republic has become the first European health authority to grant a national authorisation allowing the use of TLX591-CDx.
TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11) is a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET).
The company said this authorization enables Czech physicians to use TLX591-CDx under a Specific Therapeutic Programme (STP) that allows medical products intended for the treatment, prevention or diagnosis of conditions severely affecting human health to be used prior to being granted a full European marketing authorization.
"Telix is collaboratively pursuing such temporary approvals in a number of European countries, concurrent with marketing authorisation applications," said the company, adding the STP authorization is valid until 31 December 2022.
It allows for the use of TLX591-CDx for the diagnostic imaging of prostate cancer using PET/CT or PET/MRI for the purposes of primary staging of high-risk disease with a view to early identification of metastases, localisation of prostate cancer in patients with PSA progression following radical treatment and the identification of patients with extensive generalised prostate cancer where radical life-saving treatment is not indicated.
Telix CEO Dr Christian Behrenbruch said, “We wish to acknowledge the outstanding leadership of the Czech Society of Nuclear Medicine, the Nuclear Medicine Institute at General University Hospital Prague, and the First Faculty of Medicine at Charles University Prague, in preparing and submitting the application for the Specific Treatment Programme use of TLX591-CDx, to the Czech Ministry of Health.
"The Czech Republic is the first European country to grant broad patient access to PSMA imaging, and we look forward to working with our distribution partner THP Medical Products to ensure this state-of-the-art imaging modality is available to all men in the Czech Republic living with prostate cancer.”