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

Project Number PC0104-000
Brand Name Darzalex
Generic Name Daratumumab
Strength 20mg/mL
Tumour Type 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 Complete
Pre Noc Submission Yes
NOC Date April 13, 2017
Manufacturer Janssen Inc.
Sponsor Janssen Inc.
Submission Date March 3, 2017
Submission Deemed Complete March 10, 2017
Submission Type Initial
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ March 17, 2017
Check-point meeting May 10, 2017
pERC Meeting July 20, 2017
Initial Recommendation Issued August 3, 2017
Feedback Deadline ‡ August 18, 2017
pERC Reconsideration Meeting September 21, 2017
Final Recommendation Issued October 5, 2017
Notification to Implement Issued October 23, 2017
Therapeutic Area Multiple Myeloma (second-line)
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.