dostarlimab


( Last Updated : October 22, 2021)
Generic Name:
dostarlimab
Project Status:
Active
Therapeutic Area:
Endometrial cancer
Manufacturer:
GlaxoSmithKline Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
PC0263-000
Call for patient/clinician input closed:
Tumour Type:
Gynecology
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum containing regimen.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
​Dostarlimab is indicated for monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum containing regimen.
  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 open09-Sep-21
Call for patient/clinician input closed29-Oct-21
Submission received07-Oct-21
Submission accepted22-Oct-21
Review initiated25-Oct-21
Draft CADTH review report(s) provided to sponsor for comment13-Jan-22
Deadline for sponsors comments24-Jan-22
CADTH review report(s) and responses to comments provided to sponsor25-Feb-22
Expert committee meeting (initial)09-Mar-22
Draft recommendation issued to sponsorMarch 21, 2022
To
March 23, 2022
Draft recommendation posted for stakeholder feedback31-Mar-22
End of feedback period14-Apr-22