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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 Open for Feedback on Recommendation
Pre Noc Submission No
NOC Date November 27, 2018
Manufacturer Janssen Inc.
Submitter 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 (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.