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Adcetris for Hodgkin Lymphoma Resubmission – Details

Project Number pCODR 10145
Brand Name Adcetris (Resubmission)
Generic Name Brentuximab Vedotin
Strength 50 mg
Tumour Type Lymphoma
Indication Hodgkin Lymphoma
Funding Request For the treatment of patients with HL after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates
Review Status Under Review
Pre Noc Submission No
NOC Date February 1, 2013
Manufacturer Seattle Genetics, Inc.
Submitter Seattle Genetics, Inc.
Submission Date August 27, 2018
Submission Deemed Complete September 11, 2018
Submission Type Resubmission
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ September 11, 2018
Check-point meeting October 23, 2018
pERC Meeting December 13, 2018
Initial Recommendation Issued (target date) January 4, 2019
Feedback Deadline (target date) ‡ January 18, 2019
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.