Last Updated : June 26, 2015
Details
FilesGeneric Name:
Obinutuzumab
Project Status:
Complete
Therapeutic Area:
Chronic Lymphocytic Leukemia
Manufacturer:
Hoffmann-La Roche Limited
Brand Name:
Gazyva
Project Line:
Reimbursement Review
Project Number:
PC0041-000
Performance Metric:
N/A — Predated performance metrics
Strength:
1000 mg/ vial
Tumour Type:
Leukemia
Indications:
Chronic Lymphocytic Leukemia
Funding Request:
In combination with chlorambucil for previously untreated chronic lymphocytic leukemia where fludarabine-based therapy is considered inappropriate
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
Hoffmann-La Roche Limited
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse
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.
pERC Meeting:
Final Recommendation Issued:
Files
‡ 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.
Last Updated : June 26, 2015