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Venetoclax (Venclexta) in combo with Obinutuzumab for CLL - Details

Project Number pCODR 10212
Brand Name Venclexta
Generic Name Venetoclax Obinutuzumab
Tumour Type Leukemia
Indication Chronic Lymphocytic Leukemia (CLL)
Funding Request Venetoclax (VENCLEXTA) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) who are fludarabine ineligible.
Review Status Pending
Pre Noc Submission Yes
NOC Date
Manufacturer AbbVie Corporation
Sponsor AbbVie Corporation
Submission Date (Target Date) April 17, 2020
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ May 1, 2020
Check-point meeting (target date)
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement 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.