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Darzalex in combo with Bortezomib, Melphalan and Prednisone for Multiple Myeloma (newly diagnosed) – Details

Project Number pCODR 10148
Brand Name Darzalex
Generic Name Daratumumab
Strength 100 mg/5mL and 400 mg/20mL
Tumour Type Myeloma
Indication Multiple Myeloma (newly diagnosed)
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 Notification to Implement Issued
Pre Noc Submission No
NOC Date November 27, 2018
Manufacturer Janssen Inc.
Sponsor Janssen Inc.
Submission Date January 4, 2019
Submission Deemed Complete January 18, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ January 18, 2019
Check-point meeting March 25, 2019
pERC Meeting June 20, 2019
Initial Recommendation Issued July 5, 2019
Feedback Deadline ‡ July 19, 2019
pERC Reconsideration Meeting August 15, 2019
Final Recommendation Issued August 29, 2019
Notification to Implement Issued September 16, 2019

‡ 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.