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Project Number | pCODR 10162 |
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Brand Name | Venclexta in combo Rituximab |
Generic Name | Venetoclax |
Tumour Type | Leukemia |
Indication | Chronic Lymphocytic 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 | Notification to Implement Issued |
Pre Noc Submission | No |
NOC Date | September 21, 2018 |
Manufacturer | AbbVie Corporation |
Sponsor | 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 | January 8, 2019 |
pERC Meeting | March 21, 2019 |
Initial Recommendation Issued | April 4, 2019 |
Feedback Deadline ‡ | April 18, 2019 |
pERC Reconsideration Meeting | May 16, 2019 |
Final Recommendation Issued | May 31, 2019 |
Notification to Implement Issued | June 17, 2019 |
‡ 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.