| Project Number | pCODR 10052 |
|---|---|
| Brand Name | Sylvant |
| Generic Name | Siltuximab |
| Strength | 100mg/vial and 400mg/vial |
| Tumour Type | Lymphoma |
| Indication | Multicentric Castleman's Disease (MCD) |
| Funding Request | For the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV)-negative and human herpes virus-8 (HHV-8)-negative |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | December 3, 2014 |
| Manufacturer | Janssen Inc. |
| Submitter | Janssen Inc. |
| Submission Date | January 30, 2015 |
| Submission Deemed Complete | February 6, 2015 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | February 13, 2015 |
| Check-point meeting | March 23, 2015 |
| pERC Meeting | May 21, 2015 |
| Initial Recommendation Issued | June 4, 2015 |
| Feedback Deadline ‡ | June 18, 2015 |
| Final Recommendation Issued | June 22, 2015 |
| Notification to Implement Issued | July 8, 2015 |
‡ 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.
