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| Project Number | pCODR 10070 |
|---|---|
| Brand Name | Cotellic |
| Generic Name | Cobimetinib |
| Strength | 20 mg tablet |
| Tumour Type | Skin and Melanoma |
| Indication | Metastatic Melanoma |
| Funding Request | In combination vermurafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | February 22, 2016 |
| Manufacturer | Hoffmann-la Roche Ltd. |
| Sponsor | Hoffmann-la Roche Ltd. |
| Submission Date | December 11, 2015 |
| Submission Deemed Complete | December 18, 2015 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | January 4, 2016 |
| Check-point meeting | February 9, 2016 |
| pERC Meeting | April 22, 2016 |
| Initial Recommendation Issued | May 5, 2016 |
| Feedback Deadline ‡ | May 19, 2016 |
| pERC Reconsideration Meeting | June 16, 2016 |
| Final Recommendation Issued | June 30, 2016 |
| Notification to Implement Issued | July 18, 2016 |
‡ 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.
