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|Project Number||pCODR 10043|
|Strength||140 mg capsule|
|Indication||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||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||November 17, 2014|
|Submission Date||August 15, 2014|
|Submission Deemed Complete||August 22, 2014|
|Submission Type||New Drug|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||August 29, 2014|
|Check-point meeting||October 3, 2014|
|pERC Meeting||December 18, 2014|
|Initial Recommendation Issued||January 9, 2015|
|Feedback Deadline ‡||January 23, 2015|
|pERC Reconsideration Meeting||February 19, 2015|
|Final Recommendation Issued||March 5, 2015|
|Notification to Implement Issued||March 20, 2015|
|Clarification||A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.|
‡ 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.