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Imbruvica for Chronic Lymphocytic Leukemia (previously untreated) – Details

Project Number pCODR 10085
Brand Name Imbruvica
Generic Name Ibrutinib
Strength 140 mg Capsule
Tumour Type Leukemia
Indication Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (previously untreated)
Funding Request For patients with previously untreated CLL/SLL for whom fludarabine-based treatment is considered inappropriate
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date July 19, 2016
Manufacturer Janssen Canada Inc.
Submitter Janssen Canada Inc.
Submission Date April 20, 2016
Submission Deemed Complete April 27, 2016
Submission Type New Indication
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ May 4, 2016
Check-point meeting June 14, 2016
pERC Meeting August 18, 2016
Initial Recommendation Issued September 1, 2016
Feedback Deadline ‡ September 16, 2016
pERC Reconsideration Meeting October 20, 2016
Final Recommendation Issued November 3, 2016
Notification to Implement Issued November 18, 2016

‡ 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.