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Venclexta in combo Rituximab for Chronic Lmphocytic Leukemia – Details

Project Number pCODR 10162
Brand Name Venclexta in combo Rituximab
Generic Name Venetoclax
Tumour Type Leukemia
Indication Chronic Lmphocytic Leukemia (CLL)
Funding Request In combination with rituximab (V+R) is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy
Review Status Under Review
Pre Noc Submission No
NOC Date September 21, 2018
Manufacturer AbbVie Corporation
Submitter AbbVie Corporation
Submission Date October 24, 2018
Submission Deemed Complete November 7, 2018
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ November 7, 2018
Check-point meeting (target date) January 8, 2019
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.