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Venclexta in combo Rituximab for Chronic Lymphocytic Leukemia – Details

Project Number PC0162-000
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 Complete
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 Initial
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
Therapeutic Area Chronic Lymphocytic Leukemia (CLL)
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.