Last Updated : March 20, 2015
Details
FilesGeneric Name:
Ibrutinib
Project Status:
Complete
Therapeutic Area:
Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma
Manufacturer:
Janssen Inc.
Brand Name:
Imbruvica
Project Line:
Reimbursement Review
Project Number:
PC0043-000
Strength:
140 mg capsule
Tumour Type:
Leukemia
Indications:
Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (previously treated)
Funding Request:
For the treatment of patients with CLL/SLL with or without deletion 17p who have received at least one prior therapy and are not considered appropriate for treatment or re-treatment with a purine analog (e.g., fludarabine)
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
Janssen Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.
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, 2015