Last Updated : April 11, 2025
Details
FilesGeneric Name:
durvalumab
Project Status:
Active
Therapeutic Area:
resectable non-small cell lung cancer (NSCLC)
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Imfinzi
Project Line:
Reimbursement Review
Project Number:
PC0372-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Imfinzi (durvalumab) in combination with chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy after surgery, is indicated for the treatment of patients with resectable (tumours 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Anticipated
indication: Imfinzi (durvalumab) in combination with chemotherapy
as neoadjuvant treatment, followed by durvalumab as monotherapy after surgery,
is indicated for the treatment of patients with resectable (tumours ≥ 4 cm
and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal
growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)
rearrangements.
- 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 | 30-May-24 |
|---|---|
| Call for patient/clinician input closed | 19-Jul-24 |
| Submission received | 13-Aug-24 |
| Submission accepted | 27-Aug-24 |
| Review initiated | 28-Aug-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 14-Nov-24 |
| Deadline for sponsors comments | 10-Apr-25 |
| Clarification: - Submission temporarily suspended - Additional information has been received and the temporary suspension of the review has been lifted | |
| CDA-AMC review report(s) and responses to comments provided to sponsor | 02-Jan-26 |
| Expert committee meeting (initial) | 14-Jan-26 |
| Draft recommendation issued to sponsor | January 27, 2026 To January 29, 2026 |
| Draft recommendation posted for stakeholder feedback | 05-Feb-26 |
| End of feedback period | 20-Feb-26 |
Files
Last Updated : April 11, 2025