New Subcutaneous Formulation of OPDIVO® Approved in Canada for Use Across All Authorized Solid Tumour Indications
Subcutaneous option of established immunotherapy offers potential to reduce time in clinic and ease infusion burden
New formulation supports adaptable care delivery in oncology settings with limited capacity or remote patient populations
The approval of a new formulation expands the administration options for an established immunotherapy, offering a subcutaneous alternative with a comparable safety profile. This additional treatment delivery method provides clinicians and patients flexibility and convenience across multiple tumour types, including melanoma, renal cell carcinoma, gastric cancer, and other solid tumours.
"The burden of traveling long distances for care can be significant, particularly for individuals living in northern or rural communities," said
The subcutaneous formulation of nivolumab is designed to reduce administration time for eligible patients which may help ease infusion chair demand and potentially allow patients to spend less time at the clinic and more time on their day-to-day lives. This is particularly beneficial in settings where capacity is limited, or patient volumes are high.
"This approval represents a meaningful advancement for patients with solid tumours and the teams that care for them," said
"As an oncology nurse, I've seen how time-consuming IV treatments can be for patients and families—especially when treatment appointments can stretch into several hours at the clinic, often requiring time off work or travel from out of town," said
For BMS, the approval of OPDIVO® SC reflects a long-standing commitment to innovating not only in treatment science, but in how cancer care is delivered.
"From redefining the oncology landscape with the first immunotherapy approvals over a decade ago to today's advancement, BMS is proud to continue pushing the boundaries of what's possible in cancer care," said
Clinical Trials Overview and Regulatory Context
OPDIVO SC® (nivolumab 1,200 mg) was evaluated in CHECKMATE-67T, a randomized, multicentre Phase 3 trial in advanced or metastatic clear cell renal cell carcinoma. A total of 495 patients were randomized to receive either OPDIVO® SC (n = 248) or intravenous (IV) nivolumab (n = 247). The study demonstrated that subcutaneous administration was noninferior to IV nivolumab in both pharmacokinetics and efficacy measures. For the two primary pharmacokinetic measures—Cavgd28 (time-averaged nivolumab serum concentration over 28 days) and Cminss (minimum steady-state serum concentration)—the geometric mean ratios were 2.10 (90% CI: 2.00–2.20) and 1.77 (90% CI: 1.63–1.93), respectively. Additionally, as a key secondary endpoint, the objective response rate (ORR), was 24% (95% CI: 19–30) in the subcutaneous nivolumab arm and 18% (95% CI: 14–24) in the IV nivolumab arm.1
In the CheckMate-67T trial, the safety of nivolumab administered subcutaneously was similar to the known safety profile of the intravenous formulation of nivolumab. Local injection-site reactions were low grade, mostly grade 1, and most resolved without treatment. The most common local site reaction was injection-site erythema.1
In a pooled dataset of nivolumab as monotherapy administered intravenously across tumour types (n = 4646) the most frequent adverse reactions (≥ 10%) were fatigue (44%), musculoskeletal pain (28%) and diarrhea (26%). The majority of adverse reactions were mild to moderate (Grade 1 or 2). The incidence of Grade 3-5 adverse reactions was 44%, with 0.3% fatal adverse reactions attributed to the study drug.1
Across multiple tumour types, use of OPDIVO® SC is supported by:
- Pharmacokinetic and safety data confirming comparability to IV formulation
- Clinical bridging to existing, well-controlled trials of IV nivolumab
Regulatory authorization in
Tumour types with supported use of OPDIVO® SC :
- Renal cell carcinoma (CHECKMATE-67T, -025, -214, -9ER)
- Melanoma (CHECKMATE-238, -76K, -066, -067, -037)
- Non-small cell lung cancer (NSCLC) (CHECKMATE-816, -017, -057)
- Head and neck squamous cell carcinoma (CHECKMATE-141)
- Urothelial carcinoma (CHECKMATE-274)
- MSI-H or dMMR colorectal cancer (CHECKMATE-142)
- Esophageal and gastroesophageal junction cancers (CHECKMATE-577, -648)
- Gastric, GEJ, and esophageal adenocarcinoma (CHECKMATE-649)1
For more information about OPDIVO® SC, including prescribing and safety information, please consult the Canadian product monograph here.
About
About
- OPDIVO® SC (nivolumab for injection) Product Monograph.
May 1, 2025 . https://www.bms.com/assets/bms/ca/documents/productmonograph/OPDIVO-SC_EN_PM.pdf
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