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|Project Number||pCODR 10086|
|Generic Name||Brentuximab vedotin|
|Indication||Hodgkin Lymphoma (post-ASCT consolidation)|
|Funding Request||For post-ASCT consolidation treatment of patients with Hodgkin Lymphoma (HL) at high risk of relapse or progression|
|Pre Noc Submission||Yes|
|Manufacturer||Seattle Genetics Inc.|
|Sponsor||Seattle Genetics Inc.|
|Clarification||Seattle Genetics Inc. has requested a voluntary withdrawal of the submission for brentuximab vedotin (Adcetris) for Hodgkin Lymphoma (post-ASCT consolidation) as the Category 2 submission requirements for a pre-NOC submission cannot be met at this time. As per pCODR Procedures B22.214.171.124 b), the pCODR program has stopped the review. The pCODR Provincial Advisory Group has agreed with the manufacturer's request.|
|Submission Date||April 5, 2016|
|Submission Deemed Complete||April 12, 2016|
|Submission Type||New Indication|
|Prioritization Requested||Not Requested|
|Stakeholder Input Deadline ‡||April 19, 2016|
|Check-point meeting||June 1, 2016|
|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.