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Gazyva for Follicular Lymphoma – Details

Project Number pCODR 10091
Brand Name Gazyva
Generic Name Obinutuzumab
Strength 1000 mg vial
Tumour Type Lymphoma
Indication Follicular Lymphoma
Funding Request In combination with chemotherapy followed by obinutuzumab monotherapy for the treatment of follicular lymphoma who have relapsed after or are refractory to a rituximab containing regimen
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date December 29, 2016
Manufacturer Hoffmann-La Roche Limited
Submitter Hoffmann-La Roche Limited
Submission Date November 4, 2016
Submission Type New Indication
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ November 18, 2016
Check-point meeting January 18, 2017
pERC Meeting March 16, 2017
Initial Recommendation Issued March 30, 2017
Feedback Deadline ‡ April 13, 2017
pERC Reconsideration Meeting May 18, 2017
Final Recommendation Issued June 2, 2017
Notification to Implement Issued June 19, 2017

‡ 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.