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Bosulif for Chronic Myeloid Leukemia - Details

Project Number pCODR 10039
Brand Name Bosulif
Generic Name Bosutinib
Strength 100 mg and 500mg tablets
Tumour Type Leukemia
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.
Submitter Pfizer Canada Inc.
Submission Date May 30, 2014
Submission Deemed Complete June 30, 2014
Submission Type New Drug
Prioritization Requested No
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.