Last Updated : March 5, 2025
Details
FilesGeneric Name:
osimertinib
Project Status:
Active
Therapeutic Area:
Unresectable (stage III) non-small cell lung cancer
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Tagrisso
Project Line:
Reimbursement Review
Project Number:
PC0398-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT)
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For
the treatment of patients with locally advanced, unresectable (stage III)
non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor
receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations
(either alone or in combination with other EGFR mutations) and whose disease
has not progressed during or following platinum-based chemoradiation therapy
(CRT).
- 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 | 02-Jan-25 |
---|---|
Call for patient/clinician input closed | 24-Feb-25 |
Submission received | 13-Feb-25 |
Submission accepted | 28-Feb-25 |
Review initiated | 03-Mar-25 |
Draft CADTH review report(s) provided to sponsor for comment | 20-May-25 |
Deadline for sponsors comments | 29-May-25 |
CADTH review report(s) and responses to comments provided to sponsor | 26-Jun-25 |
Expert committee meeting (initial) | 09-Jul-25 |
Draft recommendation issued to sponsor | July 21, 2025 To July 23, 2025 |
Draft recommendation posted for stakeholder feedback | 31-Jul-25 |
End of feedback period | 15-Aug-25 |
Files
Last Updated : March 5, 2025