Last Updated : December 16, 2016
Details
FilesGeneric Name:
Daratumumab
Project Status:
Complete
Therapeutic Area:
Multiple Myeloma
Manufacturer:
Janssen Canada Inc.
Brand Name:
Darzalex
Project Line:
Reimbursement Review
Project Number:
PC0079-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Strength:
100mg/5mL and 400mg/20mL
Tumour Type:
Myeloma
Indications:
Multiple Myeloma
Funding Request:
For the treatment of patients with multiple myeloma who 1) have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD); OR 2) have failed or are intolerant to a PI and who have failed or are intolerant to an IMiD
Pre Noc Submission:
Yes
Sponsor:
Janssen Canada Inc.
Submission Date:
Submission Deemed Complete:
Submission Date (Target Date):
Prioritization Requested:
Requested and Not Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Do not reimburse
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 : December 16, 2016