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

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Generic Name:
Venetoclax Obinutuzumab
Project Status:
Complete
Therapeutic Area:
Obinutuzumab for CLL
Manufacturer:
AbbVie Corporation
Brand Name:
Venclexta
Project Line:
Reimbursement Review
Project Number:
PC0212-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Strength:
10 mg, 50 mg and 100 mg
Tumour Type:
Leukemia
Indications:
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.
Pre Noc Submission:
Yes
Sponsor:
AbbVie Corporation
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation 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.