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

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Generic Name:
Brentuximab Vedotin
Project Status:
Complete
Therapeutic Area:
HL at high risk of relapse or progression post-ASCT
Manufacturer:
Seattle Genetics, Inc.
Brand Name:
Adcetris
Project Line:
Reimbursement Review
Project Number:
PC0116-000
NOC Status at Filing:
Post NOC
Strength:
50 mg
Tumour Type:
Lymphoma
Indications:
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.
Sponsor:
Seattle Genetics, Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation:

‡ 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.