Regulatory Decision Summary for Opdivo
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
This Supplemental New Drug submission (S/NDS) was submitted to expand the renal cell carcinoma indication, to include the use of Opdivo in combination with ipilimumab, for the treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma, regardless of prior therapies.
Why was the decision issued?
Authorization was based on the results of a Phase 3 randomized, open-label controlled clinical trial (CA209214). The primary efficacy population consisted of patients in the intermediate or poor-risk category.
Treatment-naïve patients (n = 1082) with advanced or metastatic renal cell carcinoma (RCC) received either nivolumab 3 mg/kg combined with ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks, or sunitinib 50 mg once daily for 4 weeks followed by 2 weeks off, every cycle.
The nivolumab + ipilimumab arm demonstrated clinically and statistically significant overall survival (OS) and objective response rate (ORR) improvements compared to sunitinib. The median OS with nivolumab + ipilimumab was not yet reached at the time of database lock, and was 25.95 months in the sunitinib arm. The improvements in progression-free survival (PFS) were not statistically significant.
The most common serious or severe adverse drug reactions reported in at least 1% of patients were diarrhea, fatigue, pneumonitis, hypophysitis, adrenal insufficiency, colitis, hyponatremia, and increase lipase, amylase, or alanine aminotransferase (ALT).
The risks associated with this combination therapy are consistent with the safety profiles of nivolumab and ipilimumab that have previously been observed.
The recommended dose for this indication is 3 mg/kg nivolumab for the first 4 doses in combination with 1 mg/kg ipilimumab. Following the combination phase, the recommended dose of Opdivo for the single agent phase is 3 mg/kg every 2 weeks or 240 mg every 2 weeks or 480 mg every 4 weeks. View the Product Monograph for details.
Health Canada granted this application priority review.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.