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|Project Number||pCODR 10213|
|Generic Name||Brentuximab Vedotin|
|Indication||Primary Cutaneous Anaplastic Large Cell Lymphoma or CD30-Expressing Mycosis Fungoides|
|Funding Request||For the treatment of adult patients with pcALCL or CD30-expressing MF who have had prior systemic therapy.|
|Review Status||Under Review|
|Pre Noc Submission||No|
|NOC Date||December 21, 2018|
|Manufacturer||Seattle Genetics, Inc.|
|Sponsor||Seattle Genetics, Inc.|
|Submission Date||March 30, 2020|
|Submission Deemed Complete||April 15, 2020|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||April 14, 2020|
|Check-point meeting||June 2, 2020|
|pERC Meeting||September 17, 2020|
|Initial Recommendation Issued||October 1, 2020|
|Feedback Deadline ‡||October 16, 2020|
|pERC Reconsideration Meeting (target date)||November 19, 2020|
|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.