- Telix Pharmaceuticals (TLX) has received approval from the Australian drug watchdog for its prostate cancer imaging product
- The Therapeutic Goods Administrations (TGA) has granted Illuccix a broad clinical indication for certain patients with prostate cancer
- TLX says Illuccix, after radiolabeling with gallium-68, is the first commercially approved PSMA-PET imaging agent available in Australia
- The company added that the TGA approval is an important milestone as it looks to make other regulatory submissions across the Asia Pacific
- Telix Pharmaceuticals shares are up 4.37 per cent at $6.93 each
Telix Pharmaceuticals (TLX) has received approval from the Australian drug watchdog for its prostate cancer imaging product.
The company advised on Tuesday that the Therapeutic Goods Administrations (TGA) had granted Illuccix a broad clinical indication.
The imaging product can be used on prostate cancer patients who are at risk of metastasis and aren’t suitable for initial definitive therapy.
Additionally, it applies to patients with prostate cancer who have suspected recurrence based on elevated serum prostate specific antigen levels.
TLX has welcomed the TGA approval and explained Illuccix, after radiolabeling with gallium-68, was now the first commercially approved PSMA-PET imaging agent available within Australia.
Telix President of APAC David Cade said he was pleased patients across Australia would be able to access the imaging agent.
“This new mode of imaging has been recognised in leading clinical practice guidelines as superior to conventional imaging with CT1 or MRI2, for the staging of prostate cancer,” Dr Cade said.
“Illuccix attaches toprostate cancer cells expressing PSMA and can be picked up by a PET scanner, giving physicians the ability to visualise tumour cells, including very small metastases, wherever they are in the body.”
Telix CEO Christian Behrenbruch added that the TGA approval was an important milestone as it looks to make other regulatory submissions across the Asia Pacific.
“PSMA-PET imaging has been one of the most important developments in prostate cancer management in recent years,” Dr Behrenbruch said.
“As an Australian company, we are especially pleased to be delivering the first TGA-approved, GMP manufactured PSMA-PET imaging agent that will be widely available to Australian patients.
“The TGA is a sophisticated regulatory authority that is highly regarded in the Asia Pacific region. This approval is an important milestone for Telix, demonstrating the approvability of Illuccix and establishing a blueprint for a series of near-term regulatory submissions and reviews in other important markets across the Asia Pacific.”
Telix Pharmaceuticals shares were up 4.37 per cent at $6.93 each at 11:31 am AEDT.