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:
Contact:
Medicinal Ingredient(s):
Atezolizumab
Control Number:
254159
Brand/Product Name:
Tecentriq
Therapeutic Area:
Antineoplastic agent
Type of Submission:
Supplement to a New Drug Submission
Decision Issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
The purpose of this Supplement to a New Drug Submission (SNDS) was to support the withdrawal of the following indication that was authorized under the Notice of Compliance with Condition (NOC/c) policy:
Tecentriq (atezolizumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who:
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Have disease progression during or following platinum-containing chemotherapy; or
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Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Why was the decision issued?
The Sponsor, Hoffmann-La Roche Limited, voluntarily withdrew the following indication that was authorized under the NOC/c policy:
Tecentriq (atezolizumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who:
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Have disease progression during or following platinum-containing chemotherapy; or
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Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Withdrawal was based on the rapidly evolving treatment landscape in prior-platinum (second-line) metastatic urothelial carcinoma with the emergence of new fully approved treatment options, as well as delayed results of the alternative confirmatory study. This decision was not based on any new data or safety concerns. The proposed revisions of the Product Monograph (PM) in support of the removal of the particular indication are considered acceptable.
A Notice of Compliance (NOC) was granted to this submission.
For further details about Tecentriq please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2022-03-29
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
N/A
Prescription Status:
Available by prescription only
Date Filed:
2021-06-25