| 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 |
| Sponsor | 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.
