Health Canada has approved with conditions the immunotherapy drug, Tecentriq, for the treatment of patients with locally advanced or metastatic urothelial carcinoma, according to – Hoffmann-La Roche Ltd. (Roche Canada).
Early data suggests Tecentriq, also known as atezolizumab, has “strong efficacy” for metastatic bladder cancer patients, a statement from the company said. Tuesday’s announcement closely followed earlier news from south of the border that the United States Food and Drug Administration has approved Tecentriq for the treatment of advanced bladder cancer.
Health Canada said the drug can be administered to patients with locally advanced or metastatic urothelial carcinoma (mUC) who:
- Have disease progression during or following platinum-containing chemotherapy
- Have disease progression within 12 months of neoadjuvant (before surgery) or adjuvant (after surgery) treatment with platinum-containing chemotherapy2
“Metastatic urothelial cancer progressing on cisplatin-based chemotherapy is a disease that carries a poor prognosis and has limited treatment options,” said Dr. Srikala Sridhar, MD FRCPC, associate professor of medicine, University of Toronto, and head of the genitourinary medical oncology group at the Princess Margaret Cancer Center. “Health Canada’s approval of Tecentriq, a PD-L1 targeted immunotherapy, is good news for our patients as it provides a new treatment option in a disease that has seen no new drugs approved in over three decades.”
Each year, an estimated 8,700 Canadians are diagnosed with bladder cancer. The disease is the fifth most common cancer in Canada.
More than 90 per cent of urothelial cancers originate in the bladder, and urothelial carcinoma (UC) is the most common subtype of bladder cancer.
While advanced UC is less common, it is associated with a poor prognosis and has limited treatment options, according to Roche.
“Living with advanced bladder cancer was a downhill struggle,” said Ed London, bladder cancer patient. “Finding out there was a new treatment option available to me through a clinical trial allowed me to focus on other things that are important to me.”
Tecentriq works by reactivating a patient’s immune system to fight the tumour.
A protein called PD-L1 can allow cancer cells to hide from the immune system and prevent it from being able to recognize and kill the cancer.
Tecentriq is designed to block PD-L1 and is thought to boost the body’s own immune system to target and kill cancer cells.
Health Canada’s approval of Tecentriq is based on the Phase II IMvigor 210 study, sponsored by Roche.
IMvigor 210 is an open-label, multi centre, two-cohort Phase II study that evaluated the safety and efficacy of Tecentriq in patients with locally advanced or metastatic urothelial carcinoma (also known as urothelial bladder cancer), regardless of their primary tumour location (i.e., bladder, renal pelvis, ureter, urethra).
Health Canada has approved Tecentriq under provisions made in its Notice of Compliance with Conditions (NOC/c) policy. This policy facilitates earlier access to promising new medicines that treat, prevent or diagnose serious, life-threatening and/or severely debilitating diseases for which there is no alternative medicine available in Canada, or where the new medicine offers a significant improvement through its risk/benefit profile over existing medicines.
“While bladder cancer is one of the most common cancers, research funding lags behind that of most other cancers, so it’s exciting to see advancements being made in the treatment of this disease,” says Tammy Northam, executive director at Bladder Cancer Canada. “This new treatment provides a much-needed option for Canadians living with the disease – and one that could mean more time with friends and loved ones.”