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Adcetris for Hodgkin Lymphoma (post-ASCT consolidation) – Details

Project Number pCODR 10086
Brand Name Adcetris
Generic Name Brentuximab vedotin
Tumour Type Lymphoma
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
Review Status Withdrawn
Pre Noc Submission Yes
NOC Date
Manufacturer Seattle Genetics Inc.
Submitter 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 B3.1.6.2 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.