| Project Number | pCODR 10104 |
|---|---|
| Brand Name | Darzalex |
| Generic Name | Daratumumab |
| Strength | 20mg/mL |
| Tumour Type | Myeloma |
| Indication | Multiple Myeloma (second-line or beyond) |
| Funding Request | In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | April 13, 2017 |
| Manufacturer | Janssen Inc. |
| Sponsor | Janssen Inc. |
| Submission Date | March 3, 2017 |
| Submission Deemed Complete | March 10, 2017 |
| Submission Type | New Indication |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | March 17, 2017 |
| Check-point meeting | May 10, 2017 |
| pERC Meeting | July 20, 2017 |
| Initial Recommendation Issued | August 3, 2017 |
| Feedback Deadline ‡ | August 18, 2017 |
| pERC Reconsideration Meeting | September 21, 2017 |
| Final Recommendation Issued | October 5, 2017 |
| Notification to Implement Issued | October 23, 2017 |
‡ 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.
