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?
The purpose of this submission was to seek authorization for the marketing of Tecentriq (atezolizumab) as first-line treatment, in combination with nab-paclitaxel, for patients with advanced triple-negative breast cancer whose tumours express PD-L1 ≥ 1% and who have not received prior chemotherapy for metastatic disease.
After evaluation of the submitted data package, Health Canada authorized (with conditions) the following: Tecentriq (atezolizumab) in combination with nab-paclitaxel, is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%, and who have not received prior chemotherapy for metastatic disease.
A Notice of Compliance with Condition (NOC/c) was recommended and issued.
Why was the decision issued?
The market authorization was primarily based on the promising efficacy results from a randomized, double-blind, multi-centre trial, enrolled subjects with locally advanced or metastatic TNBC. This study demonstrated a modest clinical improvement in the co-primary endpoint of investigator-assessed progression-free survival (PFS) favouring the atezolizumab + nab-paclitaxel (atezo + nP) arm compared to the placebo+nab-paclitaxel (pl + nP) arm (median improvement of 1.67 months) for the intent-to-treat (ITT) population. The large subpopulation of patients whose tumours were PD-L1-positive, the target population for the proposed indication, experienced a more clinically meaningful improvement in the same endpoint (median improvement of 2.50 months). However, results for the co-primary endpoint of overall survival (OS) for the ITT population, while also favouring the atezo + nP arm, did not reach statistical significance at this interim analysis.
The safety profile gave no new safety signals. In combination with nab-paclitaxel, the proportion of all grade and grade 3-4 adverse events (AEs) and AE of special interest (AESI) toxicities increased compared to those reported in the placebo plus nab-paclitaxel arm. The incidence of peripheral neuropathy, immune-related rash, and immune-related hypothyroidism were higher in the atezolizumab-assigned patients.Overall, for both ITT and PD-L1-positive safety populations, the safety profile for the combination therapy was considered acceptable when administered by well-trained staff.
The promising nature of the results above show a strong trend toward a positive benefit / risk assessment. Lingering uncertainty remains over the OS endpoint which is currently immature, exploratory, and could only be informally tested in light of the non-significant OS results for the ITT population. Therefore, an NOC/c regulatory decision for the proposed indication for PD-L1-positive patients has been recommended. An analysis of more mature OS data provided from the final report for the pivotal study will be requested as a condition of approval under the NOC/c policy in order to more confidently substantiate the improvement in OS noted in the PD-L1 subgroup.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| TECENTRIQ | 02492393 | HOFFMANN-LA ROCHE LIMITED | ATEZOLIZUMAB 840 MG / 14 ML |