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Imbruvica for Mantle Cell Lymphoma (relapsed/refractory)

Project Number pCODR 10073
Brand Name Imbruvica
Generic Name Ibrutinib
Strength 140 mg capsule
Tumour Type Lymphoma
Indication Mantle Cell Lymphoma
Funding Request For the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL)
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date June 24, 2015
Manufacturer Janssen Inc.
Submitter Janssen Inc.
Submission Date January 29, 2016
Submission Deemed Complete February 5, 2016
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ February 12, 2016
Check-point meeting March 31, 2016
pERC Meeting June 16, 2016
Initial Recommendation Issued June 30, 2016
Feedback Deadline ‡ July 15, 2016
Final Recommendation Issued July 19, 2016
Notification to Implement Issued August 4, 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.