A novel drug which assists neurosurgeons to better visualize 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 (GBM), which are tumors that typically have a very poor prognosis. GLIOLAN is indicated in adult patients for visualization of malignant tissue during surgery for malignant gliomas that are glioblastoma multiforme (GBM) on preoperative imaging, and who are intended for resection of the tumour.
GLIOLAN causes brain tumors (gliomas) to become fluorescent and glow during surgery. This enables neurosurgeons to better visualise these tumours and more completely remove them. GLIOLAN is given to the patient as a drink three hours before surgery. During surgery, a modified neurosurgical microscope fitted with a specialized blue operating light is used, which causes cancerous tissue to glow fluorescent red whilst normal brain tissue appears blue.
Melbourne bio-pharmaceutical company Specialised Therapeutics Australia Pty Ltd (STA) in-licenses the drug from German partner photonamic GmbH and Co. KG.
Announcing the TGA approval, STA chief executive officer Mr Carlo Montagner said 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 said.
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 GBM patients.
The chief executive officer of photonamic Mr Ulrich Kosciessa said, The approval in Australia is another milestone in our global development of GLIOLAN, which is now registered in more than 30 countries world wide.
GLIOLAN 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 STA has...