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:

Atineoplastic Agent

Type of submission:

Supplement to a New Drug Submission (SNDS)

Control number:

237371
What was the purpose of this submission?

 

The Supplement to a New Drug Submission was filed to seek market authorization of Tecentriq as:

 

"monotherapy for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have high programmed cell death ligand 1 (PD-L1) expression as determined by a validated test and who do not have Epithelial Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) genomic tumour aberrations."

 

 

After evaluation of the submitted data package, Health Canada authorized Tecentriq as:

 

 

"monotherapy for the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells [TCs] or PD-L1 stained tumour-infiltrating immune cells [ICs] covering ≥ 10% of the tumour area), as determined by a validated test and who do not have EGFR or ALK genomic tumour aberrations."

 

 

Why was the decision issued?

 

Market authorization of Tecentriq was based on a pivotal trial conducted in newly diagnosed metastatic NSCLC patients with positive PD-L1 expression (≥ 1% on tumour cells [TCs] or ≥ 1% of tumour area occupied by infiltrating immune cells [ICs]). Patients were randomized 1:1 to receive Tecentriq or chemotherapy. Tecentriq was administered at a fixed dose of 1,200 mg intravenously (IV) every 3 weeks until loss of clinical benefit or unacceptable toxicity.

The primary efficacy analysis was based on comparing overall survival (OS) in metastatic NSCLC patients receiving Tecentriq monotherapy versus those receiving chemotherapy in the high PD-L1 subgroup (TCs ≥ 50% or ICs ≥ 10%) without ALK or EGFR gene aberrations (TC3 or IC3-WT). The pre-defined interim primary efficacy analysis in the TC3 or IC3-WT subgroup demonstrated a statistically significant and clinically meaningful improvement in OS of Tecentriq over chemotherapy. The median OS was 20.2 months in the Tecentriq arm vs 13.1 months in the chemotherapy arm.

The most common adverse reactions (ADRs) reported in at least 10% of the patients in the Tecentriq arm included nausea, constipation, diarrhea, anemia, asthenia, fatigue, pyrexia, dyspnea, cough, decrease appetite, and increased alanine transferase. The predominant risks associated with Tecentriq were immune-mediated, which is consistent with its mechanism of action. The safety findings are consistent with the known safety profile of Tecentriq in the monotherapy setting. All risks associated with Tecentriq are adequately captured in the Product Monograph.

The recommended dose of the drug is 840 mg intravenous (IV) infusion every 2 weeks, 1,200 mg IV infusion every 3 weeks or 1,680 mg IV infusion every 4 weeks. These dosing regimens are consistent with those in previously authorized indications for Tecentriq in the monotherapy setting. View the Tecentriq Product Monograph for details.

In view of the substantial OS benefit of Tecentriq monotherapy over chemotherapy with a manageable safety profile, the benefit outweighs the risk in the proposed indication.

 

Decision issued

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