For the past nine months, medical news has been dominated by COVID-19. So it was refreshing to hear about Gleolan, 5-aminolevulinic acid hydrochloride (5-ALA) powder for oral solution for marketing in Canada. It recently received a Notice of Compliance from Health Canada and is indicated in patients with glioma World Health Organization (WHO) Grades III or IV (suspected on preoperative imaging), as an adjunct for the visualization of malignant tissue during surgery.
“Every day in Canada it is estimated that 27 new primary brain tumours will be diagnosed,” says Susan Marshall, CEO for Brain Tumour Foundation of Canada, which supports the 55,000 people in Canada affected by brain tumours.
With limited treatment options, new advancements that assist neurosurgeons in successfully removing brain tumours brings hope to patients facing this often devastating disease. Gleolan is an imaging agent that makes high-grade gliomas (malignant, rapidly progressive brain tumors) fluoresce under blue light. Gleolan assists neurosurgeons to better visualize and more completely remove these gliomas as after administration, areas within the tumour glow pink or red, and healthy brain tissue appears blue when exposed to a special blue light during surgery. Glioblastoma multiforme (WHO Grade IV), the most common glial tumor, accounting for approximately 80 percent of patients with primary malignant brain tumors, have a median survival of 12 to 15 months. In the absence of treatment, the median survival for patients with glioblastoma is between three and four months.
International studies have 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.
Gleolan is already approved for use in more than 40 countries, including Germany, United States, United Kingdom, Japan, South Korea, Australia and New Zealand, and the approval in Canada is another milestone in the global development of the drug.
Dr. Roberto Diaz of the McGill University Health Centre told me he has used Gleolan in two cases to assist in the resection of glioblastoma (brain cancer). “I found the use of Gleolan allowed for increased confidence in distinguishing brain cancer invaded brain from normal brain, allowing me to maximize the extent of cancer cell removal,” he said.
Health Canada previously granted Medexus authorization to distribute Gleolan Canada under the Special Access Programme, which provides healthcare practitioners with access to non-marketed drugs to treat patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The company has long-term exclusive rights to market and distribute Gleolan in Canada. There are currently no other optical imaging agents approved in Canada for the purpose of visualization of malignant tissue during glioma surgery.
I asked Dr. Diaz how COVID-19 has impacted the practice of neurosurgery. He said it has done so in multiple ways. “First, we have had to adjust to testing all patients for COVID prior to undertaking surgery,” he said. “Consultations have been triaged to in-person versus telemedicine visits, depending on the severity of the condition and medical necessity for an in-person physical examination. In addition, we have had to judge the optimal timing of surgery for COVID positive and COVID negative patients during periods of restricted operating room availability. All of this has taken place while maintaining social distancing and wearing personal protective equipment religiously while at work. I work at the Montreal Neurological Institute, which was designated to maintain a COVID-free patient population to allow important and life-saving services such as stroke treatment and brain cancer surgery to continue during the pandemic. This also allowed for COVID positive patients with neurosurgical conditions to be treated at centres with specialized COVID units.”
Dr. Diaz said that he does receive consults from the emergency department at Hôpital de la Cité-de-la-Santé. The neurosurgeons working in Laval are not part of the MUHC umbrella.