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|Project Number||pCODR 10087|
|Strength||10 mg, 50 mg & 100 mg tablets|
|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|
|Pre Noc Submission||Yes|
|NOC Date||September 30, 2016|
|Clarification||AbbVie Corporation requested a voluntary withdrawal of the pCODR 10087 Venetoclax (Venclexta) for CLL Submission. As per pCODR Procedures B220.127.116.11 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 Please note that as per pCODR Procedures, Section B.6.2, if a submission is withdrawn but a pERC Initial Recommendation has been made, the pCODR program will continue to publically post the pERC Initial Recommendation.|
|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.