Bristol Myers Squibb Canada Welcomes Positive CDA Recommendation for OPDIVO® Plus YERVOY® as First-Line Treatment for MSI-H/dMMR Metastatic Colorectal Cancer

Ontario becomes the first province to list the combination under the new FAST pilot program, supporting timely access for eligible patients

MONTREAL, Dec. 17, 2025 /CNW/ - Bristol Myers Squibb Canada (BMS) today announced that Canada's Drug Agency (CDA-AMC) has issued a positive reimbursement recommendation for OPDIVO^® (nivolumab) in combination with YERVOY^® (ipilimumab)  for the first-line treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) who meet certain criteria.¹

The pCODR Expert Review Committee (pERC) based the recommendation on results from the pivotal Phase 3 CheckMate-8HW trial (N=303),which showed that the combination of OPDIVO^® plus YERVOY^® delivered a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with standard chemotherapy. After a median follow up of 42 months, the median PFS was 54.1 months with OPDIVO^® in combination with YERVOY^® versus 5.9 months with chemotherapy (HR 0.21; 95% CI: 0.14–0.31).¹

"The positive CDA recommendation reflects the durable outcomes observed with OPDIVO^® plus YERVOY^® in first-line treatment of patients with MSI-H or dMMR metastatic colorectal cancer," said Newmarket-based medical oncologist, Dr. Shaqil Kassam. "Patients living with this distinct molecular subtype of colorectal cancer have been in need of additional options in the first-line setting. This recommendation is significant and represents a notable step forward for this population."

Ontario Leads the Way with Access Through FAST Program
Following the CDA recommendation, Ontario has become the first jurisdiction in Canada to reimburse OPDIVO^® plus YERVOY^® for certain patients under the province's newly launched Funding Accelerated for Specific Treatments (FAST) program. Funding for the OPDIVO^® plus YERVOY^® combination applies to the first-line treatment of adult patients with locally advanced unresectable or metastatic MSI-H or dMMR disease and excludes individuals with significant autoimmune disease or a history of interstitial lung disease or pneumonitis.

This decision also represents a significant milestone: OPDIVO^® plus YERVOY^® is among the first therapies added to Ontario's New Drug Funding Program (NDFP) through the FAST program.

"For thousands of Ontarians facing a cancer diagnosis, fast access to treatment is critical, which is why our government is transforming cancer care and speeding up access to new and life-changing treatment options," said Sylvia Jones, Deputy Premier and Minister of Health. "As one of the first new therapies available through our historic Fast Access to Specific Treatment program, OPDIVO plus YERVOY will help more patients living with colorectal cancer get the care they need sooner as we continue our work to make advanced treatment options more accessible to those who need it most."

With its focus on accelerating review of therapies with demonstrated clinical benefit, such as OPDIVO^® plus YERVOY^®, the FAST program will enable eligible individuals with MSI-H or dMMR metastatic colorectal cancer to gain access to treatment more quickly.

"The CDA recommendation for OPDIVO^® plus YERVOY^® marks a pivotal milestone for Canadians with MSI-H or dMMR metastatic colorectal cancer," said Barry D. Stein, President and CEO, Colorectal Cancer Canada. "Ontario's decision to list the combination through the FAST framework highlights how provincial leadership can accelerate access to new treatment approaches. We hope to see similar momentum across jurisdictions so equitable access becomes a reality for patients across Canada."

"The positive CDA recommendation, combined with Ontario's early adoption of Opdivo^® plus Yervoy^® under the FAST framework, offers renewed hope for patients and their families affected by MSI-H or dMMR metastatic colorectal cancer," said Filomena Servidio-Italiano, President and CEO, Colorectal Cancer Resource & Action Network (CCRAN). "Faster access is especially important for this community, particularly given the available clinical data, and we are encouraged to see steps being taken to shorten access timelines for patients. We are hopeful that other provinces will move quickly so all Canadians can benefit from timely, equitable access."

These developments mark an important moment for patients and the clinicians who support them.

"We are pleased with the positive CDA recommendation and applaud Ontario for taking the lead with early listing through the FAST program, improving access to first-line treatment for Canadians with MSI-H or dMMR metastatic colorectal cancer," said Elaine Phillips, General Manager, Bristol Myers Squibb Canada. "We remain committed to advancing this immunotherapy combination where it can make a difference for patients and will continue to work with partners across the country to help ensure timely and equitable access for all Canadians who may benefit."

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 300 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.

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SOURCE Bristol-Myers Squibb Canada