| Project Number | pCODR 10215 |
|---|---|
| Brand Name | Odomzo |
| Generic Name | Sonidegib |
| Tumour Type | Skin and Melanoma |
| Indication | Basal Cell Carcinoma (BCC) |
| Funding Request | For the treatment of patients with metastatic basal cell carcinoma (BCC) or with locally advanced BCC who have measurable metastatic disease or locally advanced disease, which is considered inoperable or inappropriate for surgery and inappropriate for radiotherapy |
| Review Status | Pending |
| Pre Noc Submission | Yes |
| NOC Date | |
| Manufacturer | Sun Pharma Canada Inc. |
| Sponsor | Sun Pharma Canada Inc. |
| Submission Date (Target Date) | June 15, 2020 |
| Clarification | The Submitter notified pCODR that they will be unable to submit by their original target date and an updated target submission date has been provided. |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline (target date based on target submission date) ‡ | |
| Check-point meeting (target date) | |
| 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.