| Project Number | pCODR 10116 |
|---|---|
| Brand Name | Adcetris |
| Generic Name | Brentuximab Vedotin |
| Strength | 50 mg |
| Tumour Type | Lymphoma and Myeloma |
| Indication | Hodgkin’s Lymphoma at high risk of relapse or progression post-ASCT |
| Funding Request | Funding for ADCETRIS is requested for post-ASCT consolidation treatment of patients with HL at increased risk* of relapse or progression. *The definition of high risk of post-ASCT relapse or progression based on the AETHERA trial are: refractory to frontline therapy, relapsed <12 months following frontline therapy, or relapsed >12 months with extranodal involvement. |
| Review Status | Under Review |
| Pre Noc Submission | No |
| NOC Date | July 20, 2017 |
| Manufacturer | Seattle Genetics, Inc. |
| Submitter | Seattle Genetics, Inc. |
| Submission Date | August 10, 2017 |
| Submission Deemed Complete | August 24, 2017 |
| Submission Type | Resubmission |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | August 24, 2017 |
| Check-point meeting (target date) | |
| 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.