GLIOLAN (aminolevulinic acid HCl), which helps neurosurgeons to better visualize and remove malignant brain tumors, has been approved for marketing and distribution in New Zealand by Medsafe. It assists neurosurgeons to better visualize and more completely remove malignant brain tumors (gliomas) by causing them to become fluorescent and glow during surgery.
GLIOLAN is given to the patient as a drink three hours before surgery. During surgery, a neurosurgical microscope fitted with a specialized blue operating light is used, which causes cancerous tissue to glow fluorescent pink whilst normal brain tissue appears blue. This enables neurosurgeons to better visualize these tumors and more completely remove them, without damaging the neighboring healthy brain tissue.
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 tumor.
The drug will be made available in New Zealand by Australian based bio-pharmaceutical company Specialised Therapeutics (ST). ST in-licenses the drug from German partner photonamic GmbH and Co. KG.
According to New Zealand Ministry of Health 2012 figures, around 260 people in New Zealand are diagnosed with brain cancer each year, with nearly half of these being GBM.
Specialised Therapeutics’ Chief Executive Officer Mr. Carlo Montagner said regulatory approval by Medsafe is the first step in having GLIOLAN broadly available for New Zealand patients with GBM.
“Using GLIOLAN for complicated brain tumor surgery can lead to substantially improved outcomes for patients, as it improves the chances of the tumor being more completely removed,” said Montagner. “In Australia, more than 230 patients have had their surgery done using GLIOLAN, where it has been approved since November 2013.”
Leading New Zealand neurosurgeon Dr. Kelvin Woon described glioblastoma as a very aggressive brain tumor and said it had been proven that maximum (complete macroscopic) resection of the tumor increased the chances of overall survival. “Achieving this in surgery is often difficult, as the brain and tumor look similar,” he said. “Trying to find tumor margins is challenging, which can limit maximum resection.
“GLIOLAN has enabled neurosurgeons to find the ill-defined tumor margin, and gives us the confidence to go further to achieve maximum resection. Having Medsafe approval provides New Zealand patients andneurosurgeons with another weapon to treat these very aggressive tumors.”
International studies have shown that use of GLIOLAN during brain tumor surgery has nearly doubled the rate of achieving a complete resection of the tumor, which in turn has resulted in a doubling of the number of patients without progression of their brain cancer six months after surgery.
Mr Ulrich Kosciessa, said that GLIOLAN is already approved for use in 33 countries, including Germany, United Kingdom, Japan, South Korea, and Australia, and the approval in New Zealand is another milestone in the global development of the drug.
“We are delighted that ST has been able to successfully achieve an approval from Medsafe and that GLIOLAN will be available also for GBM patients in New Zealand,” he said. “Approximately 60,000 patients globally have already benefited from the use of GLIOLAN in brain tumor resection.”