Acalabrutinib (Calquence) for chronic lymphocytic leukemia - Details

Details

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Generic Name:
Acalabrutinib
Project Status:
Complete
Therapeutic Area:
Chronic Lymphocytic Leukemia (CLL)
Manufacturer:
AstraZeneca Canada Inc
Brand Name:
Calquence
Project Line:
Reimbursement Review
Project Number:
PC0211-000
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
​As monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Submission Type:
Initial
Fee Schedule:
Pending
Strength:
100 mg
Tumour Type:
Leukemia
Indications:
​As monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy
Funding Request:
As monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Sponsor:
AstraZeneca Canada Inc.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2