| Project Number | pCODR 10161 |
|---|---|
| Brand Name | TBD |
| Generic Name | Abemaciclib |
| Tumour Type | Breast |
| Indication | Advanced or metastatic breast cancer |
| Funding Request | For the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer: • In combination with an aromatase inhibitor in postmenopausal women as initial endocrine based therapy. • In combination with fulvestrant in women with disease progression following endocrine therapy. Pre- or perimenopausal women must also be treated with a gonadotropin-releasing hormone agonist. |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | |
| Manufacturer | Eli Lilly Canada Inc. |
| Submitter | Eli Lilly Canada Inc. |
| Submission Date | December 3, 2018 |
| Submission Deemed Complete | December 17, 2018 |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | December 17, 2018 |
| Check-point meeting | February 19, 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.