Regulatory Decision Summary for Ibrance
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?
A Supplemental New Drug Submission (SNDS) was submitted to seek market authorization for a new indication for Ibrance (palbociclib), for use in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer whose disease progressed after prior endocrine therapy.
Why was the decision issued?
The primary source of data supporting the proposed indication is one multicentre, randomized, placebo-controlled Phase 3 study, conducted in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer whose disease progressed after prior endocrine therapy. A total of 521 pre- and post-menopausal women were randomized 2:1 to Ibrance plus fulvestrant or placebo plus fulvestrant. The primary endpoint of the study was investigator-assessed progression-free survival (PFS). Overall survival (OS) was a secondary endpoint.
In the primary analysis, at a median follow-up of 5.6 months, patients treated with Ibrance plus fulvestrant had a statistically significant 57% reduction in the risk of disease progression (which, by definition, includes death due to any cause) compared to those treated with placebo plus fulvestrant. In an updated efficacy analysis, performed at a median duration of follow-up of approximately 15 months, objective response rate (ORR) for the patient population with measurable disease was also supportive of the experimental arm over the comparator arm.
The assessment of the safety data demonstrated that the addition of Ibrance to fulvestrant has a consistent safety profile with that previously identified for Ibrance in combination with letrozole.
The Product Monograph is the primary risk management strategy to manage the risks associated with Ibrance. The Product Monograph provides warnings pertaining to the significant adverse events reported in clinical trials, and recommendations to the prescriber regarding dose modifications/interruptions that may be required to manage adverse events. Recommendations for monitoring are also provided.
Overall, the submitted studies demonstrated evidence of clinical effectiveness and established an acceptable safety profile for the use of Ibrance plus fulvestrant in the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed after prior endocrine therapy.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.