Regulatory Decision Summary for Portrazza
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?
This new drug submission was filed to obtain market authorization for the use of Portrazza (necitumumab) in combination with gemcitabine and cisplatin for the first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer. Patients with locally advanced disease should be considered surgically incurable or incurable by virtue of ineligibility to receive curative surgery.
Why was the decision issued?
Necitumumab is a fully human IgG1 monoclonal antibody targeting and inhibiting the function of the epidermal growth factor receptor (EGFR). EGFR is a key molecule in the promotion of growth in some types of tumours. Animal model studies indicate that treatment with necitumumab results in tumor growth inhibition in the setting of non-small cell lung cancer (adenocarcinoma and squamous carcinoma types of the lung), colorectal cancer, and other types of tumors.
The pivotal 2-arm, phase III, randomized trial submitted to support the proposed indication demonstrated a small, statistically significant improvement in overall survival (OS) of 1.6 months and a 15.8% reduction in the risk of death favouring the necitumumab plus chemotherapy arm compared to the chemotherapy alone arm. A small but statistically significant improvement in progression-free survival (median improvement 0.2 months) and in time to treatment failure (median improvement 0.7 months) favouring the necitumumab-containing arm were also observed. Adverse event rates that were reported to be generally higher in the necitumumab plus chemotherapy group compared to the chemotherapy alone group included low blood magnesium levels, skin rashes, increased risk of blood clots, and weight loss. Severe (grade 3-5) adverse events reported more commonly in the necitumumab-containing arm were led by skin rashes, low blood magnesium levels, vomiting, and low blood potassium levels. The adverse events were reported to be responsive to standard medical management.
The risk management plan was reviewed and considered acceptable following clarification of the pharmacovigilance plan including the use of targeted follow-up questionnaires for key adverse events.
The benefit/risk assessment is considered favourable for necitumumab in combination with gemcitabine and cisplatin chemotherapy as front-line treatment for locally advanced or metastatic squamous non-small cell lung cancer.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations