Posted by Michael Wonder on 11 Sep 2020
Medexus reports Health Canada approval of Gleolan for use in guided surgical resection of high grade gliomas
10 September 2020 - Medexus Pharmaceuticals today announces that on 9 September 2020, it received a Notice of Compliance from Health Canada granting approval for the marketing of Gleolan in Canada.
Gleolan is a 5-aminolevulinic acid hydrochloride powder for oral solution, and is indicated as an adjunct for the visualisation of malignant tissue during surgery in patients with grades III or IV gliomas (suspected on preoperative imaging) as classified by the World Health Organization.
A pivotal Phase III study, published in The Lancet Oncology Medical Journal, has shown that use of Gleolan 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.
