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Daratumumab (Darzalex) for Multiple Myeloma

Project Number pCODR 10189
Brand Name Darzalex
Generic Name Daratumumab
Strength 100 mg/5 mL & 400 mg/20 mL
Tumour Type Multiple Myeloma
Indication Myeloma
Funding Request In combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date October 25, 2019
Manufacturer Janssen Inc.
Sponsor Janssen Inc.
Submission Date July 17, 2019
Submission Deemed Complete July 31, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ July 31, 2019
Check-point meeting September 30, 2019
pERC Meeting December 12, 2019
Initial Recommendation Issued January 3, 2020
Feedback Deadline ‡ January 17, 2020
pERC Reconsideration Meeting February 20, 2020
Final Recommendation Issued March 5, 2020
Notification to Implement Issued March 20, 2020

‡ 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.