Regulatory Decision Summary for Tecentriq
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 Supplement to a New Drug Submission (SNDS) was filed to obtain market authorization for Tecentriq (atezolizumab), an anti-programed death-ligand 1 (PD-L1) antibody, intended to treat adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic abnormalities.
Why was the decision issued?
For the indication sought, authorization was based on a single pivotal Phase III international, multi-centre, randomized, open-label trial. The trial enrolled 723 patients with metastatic non-squamous NSCLC who received one of two treatment regimens. For the control arm, patients received carboplatin + nab-paclitaxel (CnP). Patients in the treatment arm received Tecentriq + CnP.
The co-primary efficacy endpoints were investigator assessed progression free survival (PFS) and overall survival (OS). The patients that were treated with Tecentriq + CnP showed an improvement in progression free survival, as well as a clinical and statistical improvement in the median duration of overall survival: 18.6 months compared to 13.9 months in control arm, an overall improvement of 4.7 months.
The safety profile was considered acceptable in the context of the treatment of metastatic NSCLC. The occurrence of adverse events was higher in the Tecentriq + CnP arm compared to the control arm. This information is included in the Product Monograph. Please refer to the full prescribing information for nab-paclitaxel and carboplatin, in their respective Product Monographs.
Overall, the benefit/risk analysis is considered favourable for the use of Tecentriq in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with metastatic non-squamous-non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumour aberrations.
A Notice of Compliance (NOC) was recommended in accordance with the Food and Drug Regulations.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.