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| Project Number | pCODR 10189 |
|---|---|
| Brand Name | Darzalex |
| Generic Name | Daratumumab |
| Strength | 100 mg/5 mL & 400 mg/20 mL |
| 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 | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | October 25, 2019 |
| 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 | September 30, 2019 |
| pERC Meeting | December 12, 2019 |
| Initial Recommendation Issued | January 3, 2020 |
| Feedback Deadline ‡ | January 17, 2020 |
| pERC Reconsideration Meeting | February 20, 2020 |
| Final Recommendation Issued | March 5, 2020 |
| Notification to Implement Issued | March 20, 2020 |
‡ 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.
