Regulatory Decision Summary for Tarceva

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):

erlotinib (as erlotinib hydrochloride)

Therapeutic area:

Antineoplastic Agents

Type of submission:

Supplement to a New Drug Submission

Control number:

194018
What was the purpose of this submission?

 

The Supplemental New Drug Submission (SNDS) was filed to revise Tarceva (erlotinib as erlotinib hydrochloride) maintenance indication for locally advanced or metastatic non-small cell lung cancer (NSCLC), based on the results of IUNO and SATURN studies.

 

Why was the decision issued?

 

The proposed change to the current maintenance indication for Tarceva is to limit use to patients with locally advanced or metastatic non-small cell lung cancer whose tumors have activating mutations in the epidermal growth factor receptor (EGFR) gene, primarily based on results of two prospective clinical studies SATURN (BO18192) and IUNO (BO25460).

The SATURN study is a randomized, multicentre, phase III clinical trial comparing Tarceva maintenance treatment versus placebo in patients with advanced NSCLC and whose disease did not progress following 4 cycles of first-line platinum-based chemotherapy. In the subgroup of patients with EGFR mutation-positive tumors, a clinically significant progression-free survival (PFS) improvement was observed in the Tarceva arm compared with placebo. Safety findings in the SATURN study were previously evaluated by Health Canada; there is no new safety signal based on the updated analyses in patients with EGFR-mutation positive tumors. Therefore, the benefit-harm-uncertainty (BHU) profile of Tarceva maintenance treatment is positive for patients with EGFR mutation-positive NSCLC.

The IUNO study is a randomized, double-blind phase III clinical trial comparing Tarceva maintenance treatment versus Tarceva treatment upon disease progression (that is, second-line treatment) following 4 cycles of standard platinum-based chemotherapy in patients with EGFR mutation-negative NSCLC. In the IUNO study, Tarceva maintenance treatment did not extend survival compared to Tarceva second-line treatment, while resulting in very common treatment-related AEs, including severe and/or serious events. Therefore, the BHU profile of Tarceva maintenance treatment is negative for patients with advanced NSCLC whose tumors do not have EGFR mutations.

Overall, the benefits-risks profile of Tarceva for use in the maintenance treatment for NSCLC as by the revised indication for patients with EGFR mutation-positive tumors is, therefore, favorable.

 

Decision issued

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