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Imbruvica for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (previously treated) - Details

Project Number pCODR 10043
Brand Name Imbruvica
Generic Name Ibrutinib
Strength 140 mg capsule
Tumour Type Leukemia
Indication Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (previously treated)
Funding Request For the treatment of patients with CLL/SLL with or without deletion 17p who have received at least one prior therapy and are not considered appropriate for treatment or re-treatment with a purine analog (e.g., fludarabine)
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date November 17, 2014
Manufacturer Janssen Inc.
Submitter Janssen Inc.
Submission Date August 15, 2014
Submission Deemed Complete August 22, 2014
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ August 29, 2014
Check-point meeting October 3, 2014
pERC Meeting December 18, 2014
Initial Recommendation Issued January 9, 2015
Feedback Deadline ‡ January 23, 2015
pERC Reconsideration Meeting February 19, 2015
Final Recommendation Issued March 5, 2015
Notification to Implement Issued March 20, 2015
Clarification A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.

‡ 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.