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|Project Number||pCODR 10116|
|Generic Name||Brentuximab Vedotin|
|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||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||July 20, 2017|
|Manufacturer||Seattle Genetics, Inc.|
|Sponsor||Seattle Genetics, Inc.|
|Submission Date||August 10, 2017|
|Submission Deemed Complete||August 24, 2017|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||August 24, 2017|
|Check-point meeting||October 2, 2017|
|pERC Meeting||January 18, 2018|
|Initial Recommendation Issued||February 1, 2018|
|Feedback Deadline ‡||February 15, 2018|
|Final Recommendation Issued||February 21, 2018|
|Notification to Implement Issued||March 8, 2018|
‡ 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.