Therapeutic Goods Administration approval for brain tumour visualisation drug


A novel drug which assists neurosurgeons to better visualise and remove malignant brain tumours has been approved by the Therapeutic Goods Administration (TGA).

Until now, Gliolan (aminolevulinic acid HCl) has only been available via the Federal Government’s Special Access Scheme (SAS). It will now be made widely available for use by neurosurgeons to treat patients with high grade glioma, specifically glioblastoma multiforme, which are tumours that typically have a very poor prognosis, it says in a press release.

Gliolan (Specialised Therapeutics Australia) is indicated in adult patients for visualisation of malignant tissue during surgery for malignant gliomas that are glioblastoma multiforme on preoperative imaging, and who are intended for resection of the tumour.

Gliolan causes gliomas to become fluorescent and glow during surgery. This enables neurosurgeons to better visualise these tumours during resection. It is given to the patient as a drink three hours before surgery. During surgery, a modified neurosurgical microscope fitted with a specialised blue operating light is used, which causes cancerous tissue to glow fluorescent red whilst normal brain tissue appears blue.

International studies have shown that use of Gliolan during brain-tumour surgery has nearly doubled the rate of achieving a complete resection, which in turn has resulted in a doubling of the number of patients without progression of their brain cancer six months post surgery, it states in the press release.

The pivotal phase III registration study published in The Lancet Oncology reported complete resection of the malignant brain tumour tissue was achieved in 65% of patients receiving Gliolan compared to 36% of patients in the control arm. This resulted in six-month progression-free survival being achieved in 41% of patients receiving Gliolan compared to 21.1% of patients who received surgery without the use of the drug.

Neurosurgeon Lindy Jeffree has used Gliolan in 36 patients at the Royal Brisbane and Women’s Hospital, Australia, since the drug was first made available via the SAS. She regards Gliolan as an important tool in helping surgeons distinguish parts of a tumour which would otherwise be invisible to the naked eye.

She comments: “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. Gliolan has undoubtedly assisted during complex surgical procedures. Our aim is to provide optimal patient benefit. By being able to see tumours and malignant cells more clearly enables better and more thorough resection.

“I am extremely pleased to see this drug being made more widely available to improve surgical outcomes for patients with glioblastoma multiforme around the country.”

Announcing the TGA approval, Specialised Therapeutics Australia chief executive officer Carlo Montagner says Gliolan had already been used to treat over 100 Australian patients via the SAS and a number of hospitals have been quick to upgrade neurosurgical microscopes with fluorescence capability. 

“We are pleased with the positive response from neurosurgeons since Gliolan was made available via the SAS and this approval from the TGA is an extremely positive outcome,” he says.

“It has always been our intention to make this high-class compound available to all patients who may benefit. Brain-tumour surgery using Gliolan has been widely adopted throughout Europe and we expect a similar uptake in Australia to improve outcomes for all glioblastoma multiforme patients.”

The chief executive officer of photonamic Ulrich Kosciessa comments: “The approval in Australia is another milestone in our global development of Gliolan, which is now registered in more than 30 countries worldwide (Specialised Therapeutics Australia in-licenses the drug from German partner, photonamic).

“It was developed to provide neurosurgeons with an effective tool to increase radicality of brain-tumour resection without compromising safety for the patients. We are pleased that our partner Specialised Therapeutics Australia has successfully been able to achieve an approval from the TGA.”

The approval by the TGA approval brings the number of countries where Gliolan is registered to 31, including 27 in the EU as well as Japan, Korea and Taiwan. It was first approved in Europe in 2009 and is marketed by medac in Europe, Africa, South America and Asia (except Japan and Korea).

The following Australian hospitals currently perform fluorescence-guided resection of brain tumours using Gliolan:

  • Royal Brisbane and Woman’s Hospital, Queensland
  • The Wesley Hospital, Queensland
  • The Mater Private Hospital, Queensland
  • Princess Alexandra Hospital, Queensland
  • Prince of Wales Hospital, New South Wales
  • Newcastle Private Hospital, New South Wales
  • Calvary Hospital, Tasmania
  • The Royal Melbourne Hospital, Victoria
  • St Vincent’s Private Hospital, Victoria.