Last Updated : April 9, 2025
Details
Generic Name:
acalabrutinib
Project Status:
Active
Therapeutic Area:
Mantle cell lymphoma (MCL)
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Calquence
Project Line:
Reimbursement Review
Project Number:
PC0413-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Acalabrutinib in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for stem cell transplant (SCT).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Acalabrutinib in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).
- 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.
| Call for patient/clinician input open | 11-Feb-25 |
|---|---|
| Call for patient/clinician input closed | 07-Apr-25 |
| Submission received | 26-Mar-25 |
| Submission accepted | 09-Apr-25 |
| Review initiated | 10-Apr-25 |
| Draft CADTH review report(s) provided to sponsor for comment | 26-Jun-25 |
| Deadline for sponsors comments | 08-Jul-25 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | 31-Jul-25 |
| Expert committee meeting (initial) | 13-Aug-25 |
| Draft recommendation issued to sponsor | August 25, 2025 To August 27, 2025 |
| Draft recommendation posted for stakeholder feedback | 04-Sep-25 |
| End of feedback period | 18-Sep-25 |
Last Updated : April 9, 2025