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Gazyva for Chronic Lymphocytic Leukemia - Details

Project Number pCODR 10041
Brand Name Gazyva
Generic Name Obinutuzumab
Strength 1000 mg/ vial
Tumour Type Leukemia
Indication Chronic Lymphocytic Leukemia
Funding Request In combination with chlorambucil for previously untreated chronic lymphocytic leukemia where fludarabine-based therapy is considered inappropriate
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date November 25, 2014
Manufacturer Hoffmann-La Roche Limited
Submitter Hoffmann-La Roche Limited
Submission Date August 11, 2014
Submission Deemed Complete August 18, 2014
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ August 25, 2014
Check-point meeting October 1, 2014
pERC Meeting December 18, 2014
Clarification The Manufacturer had advised that Category 2 submission requirements for a pre-NOC submission will not be available to complete the submission for a November pERC meeting date. An updated target date for the pERC meeting had been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements. A confirmed pERC meeting date is posted as all pre-NOC submission requirements have been met.
Initial Recommendation Issued January 9, 2015
Feedback Deadline ‡ January 23, 2015
Final Recommendation Issued January 27, 2015
Notification to Implement Issued February 11, 2015

‡ 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.