TGA approves Gliolan brain surgery drug

Specialised Therapeutics Australia (STA) has secured TGA approval for a new drug designed to help brain surgeons better visualise and resect brain tumours.

The drug, Gliolan, will now be made widely available for neurosurgeons treating patients with glioblastoma multiforme tumours.

Gliolan is widely adopted in Europe, but was previously only available in Australia through the TGA’s Special Access Scheme (SAS).

STA in-licenses the drug from German partner photonamic GmbH. STA CEO Carlo Montagner says the drug has already been used to treat over 100 Australian patients through the SAS. Nine hospitals in Queensland, NSW, Tasmania and Victoria currently perform brain tumour removal using the drug.

Brain tumour patients are given Gliolan in drink form three hours before surgery. The drug then causes cancerous tissue to glow a fluorescent red under a specialised blue operating light, making it easier for neurosurgeons to remove tumours.

Studies suggest that the use of Gliolan can nearly double the rate of complete tumour resection and, by extension, double the number of patients without progression six months after surgery.

Prominent Australian neurosurgeon Lindy Jeffree welcomed the TGA’s decision to approve Gliolan for wider use.

“Gliolan has undoubtedly assisted during complex surgical procedures,” she said. “It makes it much easier to distinguish tumour from normal brain tissue and can make a big difference to a patient’s response to subsequent treatment and ultimately survival.”