Gazyva for Follicular Lymphoma – Details

Details

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Generic Name:
Obinutuzumab
Project Status:
Complete
Therapeutic Area:
Follicular Lymphoma
Manufacturer:
Hoffmann-La Roche Limited
Brand Name:
Gazyva
Project Line:
Reimbursement Review
Project Number:
PC0091-000
NOC Status at Filing:
Pre NOC
Strength:
1000 mg vial
Tumour Type:
Lymphoma
Indications:
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
Pre Noc Submission:
Yes
Sponsor:
Hoffmann-La Roche Limited
Submission Date:
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 with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

‡ 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.