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Darzalex for Multiple Myeloma (second-line or beyond) – Details

Project Number pCODR 10104
Brand Name Darzalex
Generic Name Daratumumab
Tumour Type Lymphoma and Myeloma
Indication Multiple Myeloma (second-line or beyond)
Funding Request In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy
Review Status Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Janssen Inc.
Submitter Janssen Inc.
Submission Date March 3, 2017
Submission Deemed Complete March 10, 2017
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ March 17, 2017
Check-point meeting (target date) May 10, 2017
pERC Meeting (target date) July 20, 2017
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.