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|Project Number||pCODR 10039|
|Strength||100 mg and 500mg tablets|
|Indication||Chronic Myeloid Leukemia|
|Funding Request||For the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior TKI therapy, and for whom subsequent treatment with imatinib, nilotinib and dasatinib is not clinically appropriate.|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||March 7, 2014|
|Manufacturer||Pfizer Canada Inc.|
|Sponsor||Pfizer Canada Inc.|
|Submission Date||May 30, 2014|
|Submission Deemed Complete||June 30, 2014|
|Submission Type||New Drug|
|Stakeholder Input Deadline ‡||June 13, 2014|
|Check-point meeting||August 13, 2014|
|pERC Meeting||March 19, 2015|
|Initial Recommendation Issued||April 2, 2015|
|Feedback Deadline ‡||April 17, 2015|
|Final Recommendation Issued||April 21, 2015|
|Notification to Implement Issued||May 6, 2015|
|Clarification||Time required for the submitter to provide additional information 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.