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Adcetris for Hodgkin’s Lymphoma (post-ASCT) Resubmission – Details

Project Number pCODR 10116
Brand Name Adcetris
Generic Name Brentuximab Vedotin
Strength 50 mg
Tumour Type Lymphoma
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.