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Perjeta for Metastatic Breast Cancer – Details

Project Number pCODR 10018
Brand Name Perjeta Herceptin Combo Pack
Generic Name Pertuzumab
Strength 420 mg/vial
Tumour Type Breast
Indication Metastatic Breast Cancer
Funding Request In combination with trastuzumab and a taxane for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date April 12, 2013
Manufacturer Hoffmann-La Roche Limited
Submitter Hoffmann-La Roche Limited
Submission Date November 2, 2012
Submission Deemed Complete November 22, 2012
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ November 19, 2012
Check-point meeting January 16, 2013
pERC Meeting May 16, 2013
Initial Recommendation Issued May 31, 2013
Feedback Deadline ‡ June 14, 2013
pERC Reconsideration Meeting July 18, 2013
Final Recommendation Issued August 1, 2013
Notification to Implement Issued August 19, 2013
Clarification A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.