Regulatory Decision Summary for VECTIBIX
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?
The purpose of this SNDS is to support the extension of the use of VECTIBIX in combination with FOLFOX for the treatment of wild-type RAS (Retrovirus Associated Sequence oncogene) patients with untreated metastatic colorectal cancer (mCRC).
Why was the decision issued?
The pivotal trial submitted in support of the proposed indication demonstrated a statistically significant median progression free survival (PFS) improvement of 2.2 months and a clinically meaningful median overall survival (OS) improvement of 5.8 months in favour of wild-type RAS patients treated with VECTIBIX plus FOLFOX compared with those treated with FOLFOX alone. These results were consistent among most subgroups and were also supported by objective response rate (ORR) findings. Moreover, the efficacy results suggest that RAS mutations were negatively predictive for VECTIBIX plus FOLFOX compared with FOLFOX alone. The safety profile of VECTIBIX in combination with FOLFOX in wild-type RAS patients appears to be favourable compared with that of FOLFOX alone. The adverse events observed in the VECTIBIX plus FOLFOX arm are generally consistent with the known safety profile of anti-EGFR therapies, and included tegument toxicity, hypomagnesemia, diarrhea, stomatitis and infusion reactions.
The overall risk benefit profile of VECTIBIX plus FOLFOX is favourable for previously untreated wild-type RAS patients with mCRC.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.