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Venetoclax (Venclexta) in combo with Obinutuzumab for CLL - Details

Project Number pCODR 10212
Brand Name Venclexta
Generic Name Venetoclax Obinutuzumab
Strength 10 mg, 50 mg and 100 mg
Tumour Type Leukemia
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 Under Review
Pre Noc Submission Yes
NOC Date April 28, 2020
Manufacturer AbbVie Corporation
Sponsor AbbVie Corporation
Submission Date April 17, 2020
Submission Deemed Complete May 7, 2020
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ May 1, 2020
Check-point meeting June 25, 2020
pERC Meeting October 15, 2020
Initial Recommendation Issued (target date) October 29, 2020
Feedback Deadline (target date) ‡ November 12, 2020
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.