HEALTH CANADA APPROVES OPDIVO™ (NIVOLUMAB) FOR THE TREATMENT OF ADVANCED OR METASTATIC RENAL CELL CARCINOMA
OPDIVO™ is the first and only anti PD-1 immuno-oncology agent in Canada approved for the treatment of advanced or metastatic renal cell carcinoma to deliver significant overall survival Announcement marks third approval for OPDIVO™ in just over six months, in a third distinct tumour type
Bristol-Myers Squibb (BMS) Canada Co. today announced that Health Canada has approved OPDIVO™ (nivolumab) injection, for intravenous use, for the treatment of adult patients with a form of kidney cancer, renal cell carcinoma (RCC), who have received prior anti-angiogenic therapy in the advanced or metastatic setting.[i]
Today’s announcement marks the first and only anti PD-1 immuno-oncology agent in Canada approved for the treatment of advanced or metastatic renal cell carcinoma to deliver significant overall survival in adults with advanced or metastatic RCC versus the current standard of care (everolimus).
This marks the third approval for OPDIVO™ in three distinct tumour types in just over six months. Health Canada approved OPDIVO™ for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancerwith progression on or after platinum-based chemotherapy on February 26, 2016, and for the treatment of adult patients with unresectable or metastatic BRAF V600 wild-type melanomain previously treated adultson September 25, 2015.
The OPDIVO™ melanoma, lung and RCC submissions received priority reviews after meeting the criteria of substantial evidence of clinical effectiveness providing an improved benefit/risk profile over existing therapies. As well, the phase 3 studies for the three tumour types were stopped early by an independent data monitoring committee for demonstrating superior overall survival in patients receiving OPDIVO™ versus standard of care.
RCC is the most common type of kidney cancer, with a low five-year survival rate of just 12 per cent in metastatic patients.[ii] Approximately 6,200 Canadians are diagnosed each year, and is more common in men than women.[iii]
“While the treatment landscape for RCC has improved over the last decade, long-term overall survival has remained elusive for many patients,” said Dr. Daniel Heng, medical oncologistat the Tom Baker Cancer Center and clinical associate professor at the Cumming School of Medicine, University of Calgary. “OPDIVO™ provides a significant survival advantage compared to a standard of care, and represents an exciting paradigm shift in the treatment of this type of cancer.”
“Immuno-oncology is a revolutionary advance in the treatment of this disease,’’ said Dr. Anil Kapoor, uro-oncologist and Professor at McMaster University, and chair of the Kidney Cancer Research Network of Canada. “OPDIVO™ is the first anti-PD-1 agent to deliver significant overall survival to patients with advanced RCC, which is an area of high unmet need. This is an exciting time for patients.”
“This is a milestone day for cancer care,” said Dr. Nawal Peacock, President and General Manager, Bristol-Myers Squibb Canada Co. “As a company, we continue to lead the way with advances in immuno-oncology with the ultimate goal of improving long term survival in a broad range of cancers. With the approvals for OPDIVO™ in melanoma, lung cancer and RCC, we are able to offer hope for more survival to more patients in Canada. Bristol-Myers Squibb Canada would like to take this opportunity to sincerely thank the patients and physicians who participated in the OPDIVO™ clinical trials.”
As an immuno-oncology (I-O) treatment, OPDIVO™ activates the body’s own immune system to attack and kill tumours. It is not only the first and only I-O treatment (anti-PD-1 agent) to deliver significant overall survival to adult patients with advanced or metastatic RCC after prior anti-angiogenic therapy, but also to adult patients with unresectable or metastatic BRAF V600 wild-type melanoma and locally advanced or metastatic non-small cell lung cancer.i
"Advanced kidney cancer is a challenging malignancy with few durable treatment options," said Heather Chappell, Executive Director Kidney Cancer Canada. “The patient community appreciates each new treatment option as an important step forward towards longer term management of this disease."
About Bristol-Myers Squibb Canada Co.
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb global operations, visit www.bms.com. Bristol-Myers Squibb Canada has been delivering innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, neuroscience, immunoscience and virology for over 80 years. Bristol-Myers Squibb Canada employs over 300 people across the country. For more information, please visit www.bmscanada.ca.