Regulatory Decision Summary for Imfinzi
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:
Contact:
Medicinal Ingredient(s):
Durvalumab
Control Number:
299521
Brand/Product Name:
Imfinzi
Therapeutic Area:
Antineoplastic Agents
Type of Submission:
Supplement to a New Drug Submission - Priority Review
Decision Issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
The purpose of the Supplement to a New Drug Submission (SNDS) is to seek market authorization for Imfinzi (durvalumab for injection) for a new indication: in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
After review, the indication recommended for authorization is:
Imfinzi in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) (Stage II to IVA) (see 14 Clinical Trials).
Why was the decision issued?
Authorization was based on the results of the MATTERHORN study, a phase 3, randomized, multicenter, double-blind, placebo-controlled trial of Imfinzi in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, in patients with resectable GC/GEJC (Stage II to IVA according to the American Joint Committee on Cancer [AJCC], 8th edition). Patients were randomized (1:1) to receive either Imfinzi (n = 474) + FLOT or placebo + FLOT (n = 474).
The study demonstrated a statistically significant improvement in event-free-survival (EFS) with Imfinzi + FLOT, as compared to placebo + FLOT, in all randomized patients (EFS HR: 0.71, 95% confidence interval [CI]: 0.58, 0.86, 2-sided p < 0.001). The median EFS was not reached in the Imfinzi arm and was 33 months in the placebo arm.
The safety results of neoadjuvant - adjuvant Imfinzi + FLOT followed by adjuvant Imfinzi monotherapy in the study were generally consistent with the established safety profiles of Imfinzi and the FLOT regimen, and is considered manageable. No new safety signals were identified. The key safety results are adequately labelled in the Product Monograph (PM). The risk mitigation strategies for Imfinzi are considered adequate.
Overall, the benefit-risk profile is favorable for Imfinzi (durvalumab for injection) for use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.
For further details about Imfinzi, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Health Canada granted priority review status to this submission.
An updated Risk Management Plan (RMP) for Imfinzi was reviewed by Health Canada and considered acceptable.
For further details about Imfinzi, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2026-01-22
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
N/A
Prescription Status:
Schedule D drug
Date Filed:
2025-06-30
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| IMFINZI | 02468816 | ASTRAZENECA CANADA INC | DURVALUMAB 50 MG / ML |