| Project Number | pCODR 10048 |
|---|---|
| Brand Name | Istodax |
| Generic Name | Romidepsin |
| Strength | 10 mg per vial |
| Tumour Type | Lymphoma |
| Indication | Peripheral T-Cell Lymphoma |
| Funding Request | For patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one prior systemic therapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | October 16, 2013 |
| Manufacturer | Celgene Inc. |
| Sponsor | Celgene Inc. |
| Submission Date | December 1, 2014 |
| Submission Deemed Complete | December 18, 2014 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | December 15, 2014 |
| Check-point meeting | February 4, 2015 |
| pERC Meeting | April 16, 2015 |
| Initial Recommendation Issued | April 30, 2015 |
| Feedback Deadline ‡ | May 14, 2015 |
| Final Recommendation Issued | May 19, 2015 |
| Notification to Implement Issued | June 3, 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.
