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Gazyva for Follicular Lymphoma (previously untreated) – Details

Project Number pCODR 10126
Brand Name Gazyva
Generic Name Obinutuzumab
Strength 25 mg/mL
Tumour Type Lymphoma
Indication Follicular Lymphoma (previously untreated)
Funding Request For the treatment of patients with previously untreated stage II bulky (>7cm), III or IV follicular lymphoma (FL)
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date July 5, 2018
Manufacturer Hoffmann-La Roche Limited
Sponsor Hoffmann-La Roche Limited
Submission Date March 15, 2018
Submission Deemed Complete March 22, 2018
Submission Type New Indication
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ March 29, 2018
Check-point meeting May 8, 2018
pERC Meeting August 16, 2018
Initial Recommendation Issued August 30, 2018
Feedback Deadline ‡ September 14, 2018
pERC Reconsideration Meeting October 18, 2018
Final Recommendation Issued November 1, 2018
Notification to Implement Issued November 16, 2018

‡ 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.