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.


Product type:

Drug

Medicinal ingredient(s):

atezolizumab

Therapeutic area:

Antineoplastic agent

Type of submission:

Supplement to a New Drug Submission

Control number:

217324
What was the purpose of this submission?

 

The purpose of this supplemental new drug submission (S/NDS) was to file clinical efficacy and safety data from a Phase III clinical trial (IMpower 150) for Tecentriq (atezolizumab), an anti-PD-L1 monoclonal antibody, to extend the licensed indication for atezolizumab for the use of atezolizumab in combination with bevacizumab, carboplatin, and paclitaxel for the treatment of adult patients with metastatic non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic non-squamous non-small cell lung cancer.

A Notice of Compliance (NOC) was recommended and issued.

 

Why was the decision issued?

 

Current authorization was based on one pivotal Phase III international, multi-centre, randomized, open-label trial, This trial enrolled 1202 patients with metastatic non-squamous non-small cell lung cancer who received one of three treatment regimens, 2 new treatment regimens compared to one of the standard of care regimens. For this indication, only the comparison between two of the treatment arms was reviewed which related to the requested indication. Patients in the standard of care (control arm) received bevacizumab, paclitaxel, and carboplatin. Patients in the treatment arm received Tecentriq, bevacizumab, paclitaxel, and carboplatin.

The co-primary efficacy endpoints were investigator assessed progression free survival and overall survival. The patients that were treated with Tecentriq, bevacizumab, paclitaxel, and carboplatin demonstrated a statistically significant improvement in progression free survival, as well as a clinically and statistical improvement in overall survival of 4.5 months, with a median overall survival of 19.2 months compared to 14.7 months in the patients treated with one of the current standard of care treatments - bevacizumab + carboplatin and paclitaxel.

The safety profile was considered acceptable in the context of the treatment of metastatic NSCLC.

While no new adverse events of special interest were identified in this study, an overall higher frequency of adverse events was observed in the four-drug regimen of Tecentriq + bevacizumab + carboplatin and paclitaxel compared to bevacizumab + carboplatin and paclitaxel. This information is included in the Product Monograph.

Overall the benefit/risk analysis is considered favourable for the use of Tecentriq in combination with bevacizumab, paclitaxel and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic non-squamous NSCLC.

Please refer to the full prescribing information for bevacizumab, paclitaxel and carboplatin, in the respective Product Monographs.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.