mirvetuximab soravtansine

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Generic Name:
mirvetuximab soravtansine
Project Status:
Active
Therapeutic Area:
Epithelial ovarian, fallopian tube, or primary peritoneal cancer
Manufacturer:
AbbVie Corporation
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
PC0394-000
Call for patient/clinician input closed:
Tumour Type:
Gynecology
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with folate receptor-alpha (FR) positive*, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
​For the treatment of adult patients with folate receptor-alpha (FRα) positive*, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
  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 open17-Jan-25
Call for patient/clinician input closed18-Mar-25
Submission received03-Mar-25
Submission accepted18-Mar-25
Review initiated19-Mar-25
Draft CADTH review report(s) provided to sponsor for comment13-Jun-25
Deadline for sponsors comments24-Jun-25
CDA-AMC review report(s) and responses to comments provided to sponsor31-Jul-25
Expert committee meeting (initial)13-Aug-25
Draft recommendation issued to sponsorAugust 25, 2025
To
August 27, 2025
Draft recommendation posted for stakeholder feedback04-Sep-25
End of feedback period18-Sep-25