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Imbruvica for Waldenström’s Macroglobulinemia - Details

Project Number pCODR 10082
Brand Name Imbruvica
Generic Name Ibrutinib
Strength 140mg Capsules
Tumour Type Lymphoma
Indication Waldenstrom's Macroglobulinemia
Funding Request For the treatment of patients with Waldenström’s Macroglobulinemia who have received at least one prior therapy
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date March 31, 2016
Manufacturer Janssen Canada Inc.
Submitter Janssen Canada Inc.
Submission Date April 21, 2016
Submission Deemed Complete April 28, 2016
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ May 5, 2016
Check-point meeting June 23, 2016
pERC Meeting August 19, 2016
Clarification Please note that the August pERC meeting was conducted over two days. The original target date for the posting of pERC Initial Recommendation remains as September 1, 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.