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Venclexta for Chronic Lymphocytic Leukemia (with 17p deletion) – Details

Project Number pCODR 10087
Brand Name Venclexta
Generic Name Venetoclax
Strength 10 mg, 50 mg & 100 mg tablets
Tumour Type Leukemia
Indication Chronic Lymphocytic Leukemia (with 17p deletion)
Funding Request For the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and have a 17p deletion
Review Status Withdrawn
Clarification AbbVie Corporation requested a voluntary withdrawal of the pCODR 10087 Venetoclax (Venclexta) for CLL Submission. As per pCODR Procedures B3.1.6.2 b), the pCODR Provincial Advisory Group has agreed to the request to withdraw and decided to not continue the review as a PAG Submission. Please note that as per pCODR Procedures, Section B.6.2, if a submission is withdrawn but a pERC Initial Recommendation has been made, the pCODR program will continue to publically post the pERC Initial Recommendation.
Pre Noc Submission Yes
NOC Date September 30, 2016
Manufacturer AbbVie Corporation
Submitter AbbVie Corporation
Submission Date July 8, 2016
Submission Deemed Complete July 26, 2016
Submission Type New Drug
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ July 22, 2016
Check-point meeting September 14, 2016
pERC Meeting November 17, 2016
Initial Recommendation Issued December 1, 2016
Feedback Deadline ‡ December 15, 2016
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.