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| Project Number | pCODR 10024 |
|---|---|
| Brand Name | Kadcyla |
| Generic Name | Trastuzumab emtansine |
| Strength | 100mg and 160 mg vial |
| Tumour Type | Breast |
| Indication | Metastatic Breast Cancer |
| Funding Request | The treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab and a taxane |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | September 11, 2013 |
| Manufacturer | Hoffman-La Roche Ltd. |
| Sponsor | Hoffman-La Roche Ltd. |
| Submission Date | March 15, 2013 |
| Submission Deemed Complete | March 22, 2013 |
| Submission Type | New Drug |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | April 2, 2013 |
| Check-point meeting | July 25, 2013 |
| pERC Meeting | October 17, 2013 |
| Initial Recommendation Issued | October 31, 2013 |
| Feedback Deadline ‡ | November 15, 2013 |
| pERC Reconsideration Meeting | December 19, 2013 |
| Final Recommendation Issued | January 10, 2014 |
| Notification to Implement Issued | January 27, 2014 |
| 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.
