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Venclexta for Chronic Lymphocytic Leukemia – Details

Project Number pCODR 10105
Brand Name Venclexta
Generic Name Venetoclax
Strength 10mg, 50 mg & 100mg tablet
Tumour Type Leukemia
Indication Chronic Lymphocytic Leukemia
Funding Request As monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and who have failed a B-Cell Receptor Inhibitor (BCRi)
Review Status Under Review
Pre Noc Submission No
NOC Date September 30, 2016
Manufacturer AbbVie Corporation
Submitter AbbVie Corporation
Submission Date July 10, 2017
Submission Deemed Complete July 17, 2017
Submission Type New Indication
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ July 24, 2017
Check-point meeting September 7, 2017
pERC Meeting November 16, 2017
Initial Recommendation Issued November 30, 2017
Feedback Deadline ‡ December 14, 2017
pERC Reconsideration Meeting (target date) February 15, 2018
Clarification The pCODR Expert Review Committee (pERC) was not able to complete its deliberations at the target meeting date of January 18, 2018. pERC will continue its deliberations for venetoclax on February 15, 2018 (new target).
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.