Regulatory Decision Summary for Perjeta and Perjeta - Herceptin
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?
The purpose of this submission was to expand the authorization of Perjeta (pertuzumab), in combination with trastuzumab and chemotherapy, for the neoadjuvant treatment of HER2-positive early breast cancer (EBC). After evaluation of the submitted data package, Health Canada authorized Perjeta, in combination with trastuzumab and chemotherapy, for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or EBC (either >2 cm in diameter or node positive).
Perjeta has previously been authorized in combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive EBC with lymph node positive and/or hormone receptor negative disease (see Perjeta Product Monograph).
Why was the decision issued?
Authorization was based on the results of a randomized study designed to evaluate the breast pathologic response rate (pCR) in HER2-positive EBC patients after receiving 4 cycles of one of four neoadjuvant treatments: trastuzumab plus docetaxel, Perjeta plus trastuzumab and docetaxel, Perjeta plus trastuzumab, or Perjeta plus docetaxel. The breast pCR was defined as the absence of residual disease in the resected breast tissue following neoadjuvant treatment.
The results demonstrated that a higher percentage of patients achieved a pCR with Perjeta plus trastuzumab and docetaxel compared to trastuzumab and docetaxel (45.8% versus 29.0%, respectively). Evidence in support of long-term benefit was based on an improvement in invasive disease free survival (iDFS) reported with adjuvant treatment of Perjeta, in combination with trastuzumab and chemotherapy, compared to placebo plus trastuzumab and chemotherapy in HER2-positive EBC patients at high risk for recurrence (see Perjeta Product Monograph for further details).
The most common adverse reactions that occurred in ≥ 20% of patients who received neoadjuvant Perjeta plus trastuzumab and docetaxel were fatigue, asthenia, mucosal inflammation, alopecia, rash, diarrhea, nausea, neutropenia and myalgia.
The recommended initial dose of Perjeta is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks by a dose of 420 mg administered over a period of 30 to 60 minutes. View Perjeta Product Monograph for details.
Based on the totality of data, the benefit-risk profile was considered positive. A Notice of Compliance was recommended.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.