Telix Pharmaceuticals Limited (ASX: TLX) has been granted national authorisation allowing the use of TLX591- CDx by the Ministry of Health of the Czech Republic, a European first.
The national authorisation, which is specific to Telix’s prostate cancer imaging product, enables Czech physicians to use TLX591-CDx {Kit for the preparation of 68Ga-PSMA-11) 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.
Telix is collaboratively pursuing such temporary approvals in a number of European countries, concurrent with marketing authorisation applications.
Under the STP authorisation, which is valid until December 31, 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 treatment2
- Identification of patients with extensive generalised prostate cancer for who radical life-saving treatment is not indicated
The President of the Czech Society of Nuclear Medicine, Dr David Zogala, said 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, said he wished 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 Therapeutic 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.”
Prostate cancer is the second most common cancer in men following skin cancer, with approximately 1.4 million men diagnosed with prostate cancer annually worldwide. While meaningful advances in the treatment of prostate cancer have occurred in recent years, more than 375,000 men still die from prostate cancer each year. The incidence of prostate cancer continues to increase, with the highest rates of the disease occurring in the United States, Canada, Europe and Australia and New Zealand.
