durvalumab, olaparib, carboplatin, paclitaxel

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Generic Name:
durvalumab, olaparib, carboplatin, paclitaxel
Project Status:
Active
Therapeutic Area:
Endometrial cancer that is mismatch repair proficient (pMMR)
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Imfinzi, Lynparza
Project Line:
Reimbursement Review
Project Number:
PC0366-001
Call for patient/clinician input closed:
Tumour Type:
Gynecology
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Imfinzi in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by: Imfinzi as monotherapy for endometrial cancer that is mismatch repair deficient (dMMR) Imfinzi in combination with olaparib with endometrial cancer that is mismatch repair proficient (pMMR)
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
​Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by durvalumab in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).
  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 open04-Sep-24
Call for patient/clinician input closed28-Oct-24
Submission received16-Oct-24
Submission accepted30-Oct-24
Review initiated31-Oct-24
Draft CADTH review report(s) provided to sponsor for comment22-Jan-25
Deadline for sponsors comments03-Feb-25
CADTH review report(s) and responses to comments provided to sponsor28-Feb-25
Expert committee meeting (initial)12-Mar-25
Draft recommendation issued to sponsorMarch 25, 2025
To
March 27, 2025
Draft recommendation posted for stakeholder feedback03-Apr-25
End of feedback period17-Apr-25