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| Project Number | pCODR 10005 |
|---|---|
| Brand Name | Halaven |
| Generic Name | Eribulin Mesylate |
| Strength | 1mg per 2 mL vial |
| Tumour Type | Breast |
| Indication | Metastatic Breast Cancer |
| Funding Request *Revised at Submitter's request | For the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane administered in either the adjuvant or metastatic setting. |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | December 14, 2011 |
| Manufacturer | Eisai Ltd. |
| Sponsor | Eisai Ltd. |
| Submission Date | February 9, 2012 |
| Submission Deemed Complete | February 16, 2012 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | February 24, 2012 |
| Check-point meeting | March 28, 2012 |
| pERC Meeting | May 17, 2012 |
| Initial Recommendation Issued | June 1, 2012 |
| Feedback Deadline ‡ | June 15, 2012 |
| pERC Reconsideration Meeting | July 19, 2012 |
| Final Recommendation Issued | August 2, 2012 |
| Notification to Implement Issued | August 20, 2012 |
‡ 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.
