| Project Number | pCODR 10124 |
|---|---|
| Brand Name | Bavencio |
| Generic Name | Avelumab |
| Strength | 20 mg/mL |
| Tumour Type | Skin & Melanoma |
| Indication | metastatic Merkel Cell Carcinoma |
| Funding Request | For the treatment of mMCC in previously treated adults |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | December 18, 2017 |
| Manufacturer | EMD Serono - Pfizer Alliance |
| Submitter | EMD Serono - Pfizer Alliance |
| Submission Date | October 10, 2017 |
| Submission Deemed Complete | October 17, 2017 |
| Submission Type | New Drug |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | October 24, 2017 |
| Check-point meeting | December 4, 2017 |
| pERC Meeting | February 15, 2018 |
| Initial Recommendation Issued | March 2, 2018 |
| Feedback Deadline ‡ | March 16, 2018 |
| Final Recommendation Issued | March 21, 2018 |
| Notification to Implement Issued | April 6, 2018 |
‡ 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.
