Czech Republic First European Country to Grant National Authorisation for the Use of Telix’s Prostate Cancer Imaging Product

MELBOURNE, Australia and LIÈGE, Belgium, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces today that the Ministry of Health of the Czech Republic is the first European health authority to grant a national authorisation allowing the use of TLX591-CDx (Kit for the preparation of ⁶⁸Ga-PSMA-11), a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET).

The national authorisation, which is specific to Telix’s prostate cancer imaging product, enables Czech physicians to use TLX591-CDx under a Specific Therapeutic Programme (STP), which 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 authorisation.¹

The value of PSMA imaging in the detection of prostate cancer, and its superior performance compared with conventional imaging has been demonstrated in prospective clinical studies. PSMA imaging is especially effective at detecting prostate cancer in patients with a rising PSA level following radical treatment², and in the primary staging of newly diagnosed prostate cancer.³

Under the STP authorisation, TLX591-CDx is indicated for the diagnostic imaging of prostate cancer using PET/CT or PET/MRI for the purposes of:

1. Primary staging of high-risk disease with a view to early identification of metastases
2. Localisation of prostate cancer in patients with PSA progression following radical treatment
3. Identification of patients with extensive generalised prostate cancer for who radical life-saving treatment is not indicated
   

President of the Czech Society of Nuclear Medicine, Dr. David Zogala stated, “The Czech Society of Nuclear Medicine considers this temporary approval of PSMA PET in the Czech Republic to be a very important milestone, with an immense impact on the quality of prostate cancer care. Accessibility to this valuable examination will increase across the Czech Republic, as previously it was limited to one single pioneer hospital in Pilsen. The Society would like to acknowledge all the specialists who have taken part in the preparation of the Programme documentation, the supporting societies, the distributor, and the manufacturer.”