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Brentuximab Vedotin (Adcetris) for Primary Cutaneous Anaplastic Large Cell Lymphoma or CD30-Expressing Mycosis Fungoides - Details

Project Number pCODR 10213
Brand Name Adcetris
Generic Name Brentuximab Vedotin
Strength 50 mg
Tumour Type Lymphoma
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
Prioritization Requested
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 November 19, 2020
Final Recommendation Issued (target date) December 3, 2020
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.