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Adcetris for systemic Anaplastic Large Cell Lymphoma - Details

Project Number pCODR 10021
Brand Name Adcetris
Generic Name Brentuximab vedotin
Strength 50mg/vial
Tumour Type Lymphoma
Indication Systemic Anaplastic Large Cell Lymphoma
Funding Request For second-line treatment of sALCL patients - i.e. after failure of at least one prior multi-agent chemotherapy regimen
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date February 1, 2013
Manufacturer Seattle Genetics, Inc.
Submitter Seattle Genetics, Inc.
Submission Date March 15, 2013
Submission Deemed Complete March 22, 2013
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ April 2, 2013
Check-point meeting May 8, 2013
pERC Meeting September 19, 2013
Initial Recommendation Issued October 3, 2013
Feedback Deadline ‡ October 18, 2013
pERC Reconsideration Meeting November 21, 2013
Final Recommendation Issued December 5, 2013
Notification to Implement Issued December 20, 2013
Clarification Time required for the submitter to provide additional economic information has impacted the review timeline.

‡ 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.