Bosulif for Chronic Myeloid Leukemia - Details

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Generic Name:
Bosutinib
Project Status:
Complete
Therapeutic Area:
Chronic Myeloid Leukemia
Manufacturer:
Pfizer Canada Inc.
Brand Name:
Bosulif
Project Line:
Reimbursement Review
Project Number:
PC0039-000
Strength:
100 mg and 500mg tablets
Tumour Type:
Leukemia
Indications:
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:
Complete
Sponsor:
Pfizer Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
No
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Clarification:
Time required for the submitter to provide additional information has impacted the review timeline.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Clarification:
Time required for the submitter to provide additional information has impacted the review timeline.
pERC Meeting:
Final Recommendation Issued:

‡ 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.