| Project Number | pCODR 10182 |
|---|---|
| Brand Name | Kadcyla |
| Generic Name | Trastuzumab Emtansine |
| Tumour Type | Breast |
| Indication | Early Breast Cancer (EBC) |
| Funding Request | For the adjuvant treatment of patients with HER2-positive early breast cancer, who have residual disease, after pre-operative systemic treatment. KADCYLA should be continued for 14 cycles or until disease progression or unacceptable toxicity. If KADCYLA is discontinued in the event of toxicity, treatment with trastuzumab may be continued to complete one year of HER2-directed therapy. |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | |
| Manufacturer | Hoffmann-La Roche Limited |
| Sponsor | Hoffmann-La Roche Limited |
| Submission Date | July 2, 2019 |
| Submission Deemed Complete | July 16, 2019 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | July 16, 2019 |
| Check-point meeting (target date) | August 28, 2019 |
| pERC Meeting (target date) | |
| Initial Recommendation Issued (target date) | |
| Feedback Deadline (target date) ‡ | |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued (target date) | |
| Notification to Implement Issued |
‡ 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.
