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

Project Number PC0116-000
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 Complete
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
Submission Type Resubmission
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
Therapeutic Area HL at high risk of relapse or progression post-ASCT
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.