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.
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What was the purpose of this submission?
This Priority Supplemental New Drug Submission (SNDS) was filed to obtain market authorization for a new indication for OPDIVO (nivolumab), an immune checkpoint inhibitor, for the treatment of recurrent or metastatic squamous cell cancer of the head and neck after platinum-based therapy in adults.
Upon review, OPDIVO was approved for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.
Why was the decision issued?
Patients with recurrent or metastatic squamous cell cancer of the head and neck have poor prognosis. The sponsor assessed the safety and efficacy of OPDIVO (nivolumab), an anti-PD-1 fully humanized IgG4 monoclonal antibody, in adult patients who progressed on or after platinum-based therapy compared to investigators choice therapy (either cetuximab, methotrexate or docetaxel monotherapy).
The pivotal Phase III open-label Study CA209141 submitted to support the proposed indication demonstrated a statistically and clinically significant improvement in overall survival for OPDIVO-treated patients compared to patients treated with investigators choice therapy. The median overall survival was 7.5 and 5.1 months in the OPDIVO and investigators choice therapy arms, respectively. Overall, there was a 30% reduction in the risk of death for patients treated with OPDIVO compared to patients treated with investigators choice therapy (hazard ratio = 0.70). Patients with tumour PD-L1 expression by all predefined expression levels in the OPDIVO arm demonstrated greater likelihood of improved survival compared to the investigators choice therapy arm. In contrast, there were no meaningful differences in overall survival between OPDIVO and investigators choice treated patients who were PD-L1 negative (PD-L1 < 1%).
No new safety concerns were reported in patients with squamous cell cancer of the head and neck treated with OPDIVO monotherapy compared to other approved indications. In Study CA209141, therapy was discontinued for adverse reactions in 4% of patients receiving OPDIVO and in 10% of patients receiving investigators choice therapy. Twenty four percent (24%) of OPDIVO-treated patients had a drug delay for an adverse reaction. Serious adverse reactions occurred in 7% of OPDIVO-treated patients and in 15% receiving investigators choice therapy. In study CA209141, there were 2 treatment-related deaths associated with OPDIVO (pneumonitis and hypercalcemia) versus none in patients treated with investigators choice therapy. Less common but significant adverse drug reactions associated with OPDIVO in Study CA209141 included hypophysitis, hyperglycemia, hypercalcemia, dyspnea, pulmonary embolism and pneumonia aspiration. The overall incidences of "Immune-Mediated Adverse Reactions" did not change appreciably in the OPDIVO clinical trial database by including adverse reactions from Study CA209141.
Overall, the benefit: risk profile for OPDIVO in the treatment of recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy was considered favourable.
A Notice of Compliance (NOC) was recommended.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.