Regulatory Decision Summary for Cyramza
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.
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What was the purpose of this submission?
Cyramza is an antineoplastic agent, a recombinant human monoclonal antibody (IgG1) that specifically binds to vascular endothelial growth factor (VEGF) receptor Cyramza as a single agent or in combination with paclitaxel was indicated for the treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with disease progression on or after prior platinum and fluoropyrimidine chemotherapy.
Why was the decision issued?
The market authorization was based on two pivotal Phase III, multicentre, randomized, double blind studies. When Cyramza was used as a single agent, the improvement in overall survival (OS) was 1.4 months with the reduced risk of death by 22%. When Cyramza was combined with paclitaxel therapy, the improvement in OS was 2.2 months. The safety profile is consistent with what is expected from an angiogenesis antagonist. A higher incidence rate of adverse events was observed when Cyramza was combined with paclitaxel therapy compared to Cyramza as a single agent: the incidence rate of hypertension was 25.1% versus (vs.) 5.8%, bleeding was 41.9% vs. 17.9%.
Health Canada considers that the benefit/risk profile of Cyramza (ramucirumab) as a single agent or in combination with paclitaxel is favourable for the treatment of patients for the authorized indications.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| CYRAMZA | 02443805 | ELI LILLY CANADA INC | RAMUCIRUMAB 10 MG / ML |