CDA | Evidence Driven
CDA | Evidence Driven

durvalumab

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Generic 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.
  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
Call for patient/clinician input open30-May-24
Call for patient/clinician input closed19-Jul-24
Submission received13-Aug-24
Submission accepted-
Review initiated28-Aug-24
Draft CADTH review report(s) provided to sponsor for comment14-Nov-24
Deadline for sponsors comments25-Nov-24
CADTH review report(s) and responses to comments provided to sponsor19-Dec-24
Expert committee meeting (initial)08-Jan-25
Draft recommendation issued to sponsorJanuary 20, 2025
To
January 22, 2025
Draft recommendation posted for stakeholder feedback30-Jan-25
End of feedback period13-Feb-25

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Patient and Clinician Group input View PDF
Last Updated : August 28, 2024