| Project Number | pCODR 10021 |
|---|---|
| Brand Name | Adcetris |
| Generic Name | Brentuximab vedotin |
| Strength | 50mg/vial |
| Tumour Type | Lymphoma |
| Indication | Systemic Anaplastic Large Cell Lymphoma |
| Funding Request | For second-line treatment of sALCL patients - i.e. after failure of at least one prior multi-agent chemotherapy regimen |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | February 1, 2013 |
| Manufacturer | Seattle Genetics, Inc. |
| Sponsor | Seattle Genetics, Inc. |
| Submission Date | March 15, 2013 |
| Submission Deemed Complete | March 22, 2013 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | April 2, 2013 |
| Check-point meeting | May 8, 2013 |
| pERC Meeting | September 19, 2013 |
| Initial Recommendation Issued | October 3, 2013 |
| Feedback Deadline ‡ | October 18, 2013 |
| pERC Reconsideration Meeting | November 21, 2013 |
| Final Recommendation Issued | December 5, 2013 |
| Notification to Implement Issued | December 20, 2013 |
| Clarification | Time required for the submitter to provide additional economic information has impacted the review timeline. |
‡ 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.
