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|Project Number||pCODR 10212|
|Generic Name||Venetoclax Obinutuzumab|
|Strength||10 mg, 50 mg and 100 mg|
|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||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||April 28, 2020|
|Submission Date||April 17, 2020|
|Submission Deemed Complete||May 7, 2020|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||May 1, 2020|
|Check-point meeting||June 25, 2020|
|pERC Meeting||October 15, 2020|
|Initial Recommendation Issued||October 29, 2020|
|Feedback Deadline ‡||November 12, 2020|
|pERC Reconsideration Meeting (target date)|
|Final Recommendation Issued||November 17, 2020|
|Notification to Implement Issued||December 2, 2020|
‡ 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.