Czech Republic Grants National Authorisation for the Use of Telix’s Prostate Cancer Imaging Product
Melbourne (Australia) and Liège (Belgium) – 16th February 2021. Telix announces the Ministry of Health of the Czech Republic is the first European health authority to grant a national authorization allowing the use of TLX591-CDx
Telix is pleased to announce that the Ministry of Health of the Czech Republic is the first European health authority to grant a national authorization 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 authorization, 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 authorization. Telix is collaboratively pursuing such temporary approvals in a number of European countries, concurrent with marketing authorisation applications.
Under the STP authorization, which is valid until 31st December 2022, TLX591-CDx is indicated 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
- 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.”
Telix CEO, Dr. Christian Behrenbruch added, “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.”
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