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Darzalex in combo with Bortezomib, Melphalan and Prednisone for Multiple Myeloma – Details

Project Number pCODR 10148
Brand Name Darzalex
Generic Name Daratumumab
Tumour Type Myeloma
Indication Multiple Myeloma
Funding Request In combination with bortezomib, melphalan and prednisone, for the treatment of patients with newly diagnosed multiple myeloma who are not suitable for autologous stem cell transplant
Review Status Pending
Pre Noc Submission No
NOC Date
Manufacturer Janssen Inc.
Submitter Janssen Inc.
Submission Date (Target Date) January 4, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ January 18, 2019
Check-point meeting (target date)
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.