| Project Number | pCODR 10187 |
|---|---|
| Brand Name | Libtayo |
| Generic Name | Cemiplimab |
| Strength | 50mg/mL |
| Tumour Type | Skin & Melanoma |
| Indication | Cutaneous Squamous Cell Carcinoma |
| Funding Request | For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. |
| Review Status | Under Review |
| Pre Noc Submission | No |
| NOC Date | |
| Manufacturer | Sanofi Genzyme |
| Sponsor | Sanofi Genzyme |
| Submission Date | July 9, 2019 |
| Submission Deemed Complete | July 30, 2019 |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | July 23, 2019 |
| Check-point meeting (target date) | September 17, 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.