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Daratumumab (Darzalex) for Multiple Myeloma

Project Number pCODR 10189
Brand Name Darzalex
Generic Name Daratumumab
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 Under Review
Pre Noc Submission Yes
NOC Date
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 (target date) September 30, 2019
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ 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.