New cancer and epilepsy treatments approved, offering fresh options for patient care in Canada
Health Canada has approved two therapies addressing significant treatment gaps for Canadian patients.
The first is for muscle invasive bladder cancer (MIBC), a form of urothelial carcinoma in which the tumour grows into the bladder’s muscle wall but has not spread to distant parts of the body.
In Canada, bladder cancer is the fifth most common cancer, with over 13,000 new cases annually, and about half of MIBC patients experience disease recurrence after bladder removal surgery.
The newly approved treatment combines Imfinzi (durvalumab), an immunotherapy that helps the immune system attack cancer cells, with chemotherapy drugs gemcitabine and cisplatin before surgery, followed by Imfinzi alone after surgery.
The NIAGARA Phase III trial showed this regimen reduced the risk of disease progression, recurrence, not undergoing surgery, or death by 32 percent compared to standard chemotherapy with surgery.
It also reduced the risk of death by 25 percent, with more patients remaining alive and event-free at two years.
The second approval addresses prolonged, acute, convulsive seizures in children, a type of seizure that lasts for several minutes and can cause serious short- and long-term effects if not treated promptly.
These seizures can occur in epilepsy, a chronic neurological disorder affecting nearly one in 100 Canadians, with about 13 percent of cases in children and youth.
Buccolam (midazolam hydrochloride oromucosal solution) is a benzodiazepine medication that works by calming excessive electrical activity in the brain.
Supplied in pre-filled, ready-to-use syringes, it is administered inside the cheek for rapid absorption, allowing quick seizure control and potentially avoiding hospitalisation.
Pendopharm, a division of Pharmascience Inc., will distribute Buccolam in Canada under an exclusive agreement with Germany-based Neuraxpharm Group.
