Last Updated : March 20, 2020
Details
FilesGeneric Name:
Daratumumab
Project Status:
Complete
Therapeutic Area:
Rd for MM
Manufacturer:
Janssen Inc.
Brand Name:
Darzalex
Project Line:
Reimbursement Review
Project Number:
PC0189-000
NOC Status at Filing:
Pre NOC
Strength:
100 mg/5 mL & 400 mg/20 mL
Tumour Type:
Multiple Myeloma
Indications:
Myeloma
Funding Request:
In combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Pre Noc Submission:
Yes
Sponsor:
Janssen Inc.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:
Files
‡ 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.
Last Updated : March 20, 2020