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osimertinib

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Generic 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).
  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 openJanuary 02, 2025
Call for patient/clinician input closedFebruary 24, 2025
Submission receivedFebruary 13, 2025
Submission acceptedFebruary 28, 2025
Review initiatedMarch 03, 2025
Draft CADTH review report(s) provided to sponsor for commentMay 20, 2025
Deadline for sponsors commentsMay 29, 2025
CDA-AMC review report(s) and responses to comments provided to sponsorJune 26, 2025
Expert committee meeting (initial)July 09, 2025
Draft recommendation issued to sponsorJuly 21, 2025
To
July 23, 2025
Draft recommendation posted for stakeholder feedbackJuly 31, 2025
End of feedback periodAugust 15, 2025

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Last Updated : April 16, 2025