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 Supplemental New Drug submission (S/NDS) was submitted to expand Tecentriq indication for adjuvant treatment for early stage non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥1% of tumour cells (TCs).
After evaluation of the submitted data package, Health Canada authorized Tecentriq for the following indication:
Tecentriq as monotherapy, is indicated as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TCs).
Why was the decision issued?
Authorization was based on an international, randomized, open label, phase III trial (IMpower010). The study compared the efficacy and safety of Tecentriq monotherapy versus best supportive care (BSC) in patients with Stage IB - IIIA NSCLC following complete resection and adjuvant cisplatin-based chemotherapy.
A total of 1,005 patients were randomized to receive either Tecentriq (1,200 mg intravenously every 3 weeks for 16 cycles) or BSC. An overall improvement in disease-free survival (DFS) with the Tecentriq treatment was observed in patients with Stage II - IIIA NSCLC whose tumours have PD-L1 expression on ≥ 1% of tumour cells (TCs), with median DFS not reached in Tecentriq-treated patients and a median DFS of 35.3 months in patients treated with BSC. The overall DFS improvement was driven by the treatment benefit in patients with PD-L1 expression on ≥ 50% of TCs. The median DFS in the Tecentriq cohort and the BSC cohort was not reached and 35.7 months, respectively, in patients with PD-L1 ≥ 50% TCs; and 32.8 months and 31.4 months, respectively, in patients with PD-L1 1-49% TCs.
The most common adverse reactions (ARs) reported in at least 10% of patients who received Tecentriq were cough, respiratory tract infection, hypothyroidism, fatigue, pyrexia, rash, pruritus, peripheral neuropathy, arthralgia, increased alanine aminotransferase and increased aspartate aminotransferase. Risk mitigation is achieved through monitoring, dose withholding/discontinuation and the appropriate use of systemic corticosteroid treatment when necessary. View the Tecentriq Product Monograph for details.
The recommended dose of Tecentriq is either 1,200 mg every 3 weeks, 840 mg every 2 weeks or 1,680 mg every 4 weeks intravenously.
Overall, the benefit/risk profile of Tecentriq monotherapy as adjuvant treatment is considered positive for adult patients following complete resection and no progression after platinum-based adjuvant chemotherapy for Stage II to IIIA NSCLC, whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TCs).
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations