osimertinib

Details

Generic Name:
osimertinib
Project Status:
Active
Therapeutic Area:
Non-small cell lung cancer
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Tagrisso
Project Line:
Reimbursement Review
Project Number:
PC0336-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
in combination with pemetrexed and platinum-basedchemotherapy for the first-line treatment of patientswith locally advanced (not amenable to curativetherapies), or metastatic NSCLC whose tumours haveepidermal growth factor receptor (EGFR) exon 19deletions or exon 21 (L858R) substitution mutations.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
in combination withpemetrexed and platinum-basedchemotherapy for the first-line treatment ofpatients with locally advanced (not amenableto curative therapies), or metastatic NSCLCwhose tumours have epidermal growth factorreceptor (EGFR) exon 19 deletions or exon 21(L858R) substitution mutations.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open30-Oct-23
Call for patient/clinician input closed22-Dec-23
Clarification:

- Patient input submission received from Lung Cancer Canada and the Lung Health Foundation

Submission received11-Dec-23
Submission accepted02-Jan-24
Clarification:

- Additional information has been received and the temporary suspension of the review has been lifted

Review initiated03-Jan-24
Draft CADTH review report(s) provided to sponsor for comment21-Jun-24
Deadline for sponsors comments03-Jul-24
CADTH review report(s) and responses to comments provided to sponsor01-Aug-24
Expert committee meeting (initial)14-Aug-24
Draft recommendation issued to sponsorAugust 26, 2024
To
August 28, 2024
Draft recommendation posted for stakeholder feedback05-Sep-24
End of feedback period19-Sep-24