Brain tumour visualisation drug approved in New Zealand

Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, has approved a drug that helps neurosurgeons to better visualise and remove malignant brain tumours for marketing and distribution.

The drug, called Gliolan, is given to patients with malignant brain tumours (gliomas) as a drink before surgery. During surgery a neurosurgical microscope fitted with a specialised blue operating light is used, which causes the cancerous tissue to glow fluorescent pink while normal brain tissue appears blue. This enables neurosurgeons to better visualise tumours and more completely remove them, without damaging the neighbouring healthy brain tissue.

Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant gliomas that are glioblastoma multiforme (GBM) on pre-operative imaging, and who are intended for resection of the tumour. Studies show that use of Gliolan during brain tumour surgery has nearly doubled the rate of achieving a complete resection of the tumour, which in turn has resulted in a doubling of the number of patients without progression of their brain cancer six months after surgery.

The drug will be made available in New Zealand by Australian-based biopharmaceutical company Specialised Therapeutics Australia, which in-licenses the drug from German partner photonamic. Specialised Therapeutics Australia CEO Carlo Montagner said regulatory approval by Medsafe is the first step in having Gliolan broadly available for New Zealand patients with GBM.

“Our next step is to have this important drug reimbursed and listed on the Pharmaceutical Schedule in New Zealand as soon as possible, to make this high-class compound available to all patients with GBM,” he said. “Gliolan is already under consideration for reimbursement as a high priority by PHARMAC, the New Zealand reimbursement authority.”

Gliolan was first approved in Europe in 2007 and has since benefited 60,000 patients in 33 countries, including Germany, the United Kingdom, Japan and South Korea. It has been approved in Australia since November 2013 and has so far helped 230 patients.