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| Project Number | pCODR 10019 |
|---|---|
| Brand Name | Tykerb (in combination with Letrozole) |
| Generic Name | Lapatinib |
| Strength | 250 mg |
| Tumour Type | Breast |
| Indication | Metastatic Breast Cancer |
| Funding Request | In combination with letrozole for the treatment of postmenopausal patients with hormone receptor positive metastatic breast cancer, whose tumours overexpress the ErbB2 (HER2) receptor, and who are suitable for endocrine therapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | September 30, 2010 |
| Manufacturer | GlaxoSmithKline |
| Sponsor | GlaxoSmithKline |
| Submission Date | December 14, 2012 |
| Submission Deemed Complete | December 21, 2012 |
| Submission Type | New Indication |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | January 8, 2013 |
| Check-point meeting | February 19, 2013 |
| pERC Meeting | April 18, 2013 |
| Initial Recommendation Issued | May 2, 2013 |
| Feedback Deadline ‡ | May 16, 2013 |
| pERC Reconsideration Meeting | June 20, 2013 |
| Final Recommendation Issued | July 5, 2013 |
| Notification to Implement Issued | July 22, 2013 |
‡ 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.
