New Subcutaneous Formulation of OPDIVO® Receives Positive INESSS Recommendation for Multiple Tumour Types

Milestone decision recognizes the value of SC formulation of OPDIVO^® to help support delivery flexibility

MONTREAL, Sept. 23, 2025 /CNW/ - Bristol Myers Squibb Canada (BMS) today announced that the Institut national d'excellence en santé et en services sociaux (INESSS) has issued a positive recommendation for the reimbursement of OPDIVO^® SC (nivolumab for subcutaneous injection) in Quebec across Health Canada-authorized solid tumour indications where OPDIVO^® (nivolumab) for intravenous infusion is reimbursed. This recommendation represents a meaningful step toward broader patient access to the recently approved subcutaneous formulation of OPDIVO^® and reinforces its value within Canada's evolving oncology care landscape.

The INESSS recommendation builds on the recognized therapeutic value of intravenous OPDIVO^® and reflects confidence in the clinical efficacy and safety of OPDIVO^® SC. It also signals recognition of its potential to align with healthcare system needs through an alternative mode of immunotherapy delivery. The subcutaneous formulation of nivolumab—approved by Health Canada in May 2025—can be administered in minutes, offering an additional route of administration that could support time savings in clinic for eligible patients and more flexible use of healthcare resources.
"The availability of a subcutaneous option like OPDIVO^® SC across several tumour types introduces added flexibility in how we deliver immunotherapy," said Montreal-based hematologist-oncologist, Dr. Normand Blais. "It presents an opportunity to adapt care pathways in ways that take into account both system-level demands and patient needs—an important balance as we continue to evolve cancer care."

"The availability of a subcutaneous option like OPDIVO^® SC across several tumour types introduces added flexibility in how we deliver immunotherapy," said Montreal-based hematologist-oncologist, Dr. Normand Blais. "It presents an opportunity to adapt care pathways in ways that take into account both system-level demands and patient needs—an important balance as we continue to evolve cancer care."

"As nurses, we see every day the time and energy that cancer treatment demands of patients and their families," said Annie Bombardier, RN, CSIO(C), a Montreal-based oncology nurse. "The option to receive OPDIVO^® subcutaneously means less time connected to an IV and more time for patients to focus on what matters most to them. This advancement supports both patient needs and the efficiency of our healthcare system."

OPDIVO^® SC is approved for use across currently authorized solid tumour indications in monotherapy, in the maintenance phase following combination with ipilimumab (YERVOY^®), and in combination regimens with chemotherapy or tyrosine kinase inhibitors, including:

• Renal cell carcinoma
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• MSI-H/dMMR colorectal cancer (prior treatment)
• Esophageal and gastroesophageal junction cancers
• Gastric, GEJ, and esophageal adenocarcinoma

"This positive recommendation from INESSS is an important step toward expanding access to innovative treatment options for patients in Quebec," said Elaine Phillips, General Manager, Bristol Myers Squibb Canada. "The subcutaneous formulation of OPDIVO^® reflects our ongoing commitment to delivering scientific innovation that respond to real-world needs. We look forward to continued work with healthcare partners across Canada to enable timely access to OPDIVO^® SC—supporting sustainable care that meets both patient needs and the healthcare system."

For more information on OPDIVO^® SC, including prescribing and safety information, please consult the Canadian Product Monograph here.

About Bristol Myers Squibb Canada Co. 
Bristol Myers Squibb Canada Co. 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. Bristol Myers Squibb Canada Co. employs close to 170 people across the country. For more information, please visit https://www.bms.com/ca/en.

About Bristol Myers Squibb: Transforming Patients' Lives Through Science At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what's possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

SOURCE Bristol-Myers Squibb Canada

For media requests please contact: Daphne Weatherby, Corporate Affairs, Bristol Myers Squibb Canada, [email protected]