| Project Number | pCODR 10189 |
|---|---|
| Brand Name | Darzalex |
| Generic Name | Daratumumab |
| Tumour Type | Multiple Myeloma |
| Indication | Myeloma |
| Funding Request | In combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | |
| Manufacturer | Janssen Inc. |
| Sponsor | Janssen Inc. |
| Submission Date | July 17, 2019 |
| Submission Deemed Complete | July 31, 2019 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | July 31, 2019 |
| Check-point meeting (target date) | September 30, 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.