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Darzalex for Multiple Myeloma – Details

Project Number pCODR 10079
Brand Name Darzalex
Generic Name Daratumumab
Strength 100mg/5mL and 400mg/20mL
Tumour Type Myeloma
Indication Multiple Myeloma
Funding Request For the treatment of patients with multiple myeloma who 1) have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD); OR 2) have failed or are intolerant to a PI and who have failed or are intolerant to an IMiD
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date June 29, 2016
Manufacturer Janssen Canada Inc.
Submitter Janssen Canada Inc.
Submission Date April 21, 2016
Submission Deemed Complete May 12, 2016
Submission Type New Drug
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ May 5, 2016
Check-point meeting July 8, 2016
pERC Meeting September 15, 2016
Initial Recommendation Issued September 29, 2016
Feedback Deadline ‡ October 14, 2016
pERC Reconsideration Meeting November 17, 2016
Final Recommendation Issued December 1, 2016
Notification to Implement Issued December 16, 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.