dostarlimab

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Generic Name:
dostarlimab
Project Status:
Complete
Therapeutic Area:
Endometrial cancer
Manufacturer:
GlaxoSmithKline Inc.
Brand Name:
Jemperli
Project Line:
Reimbursement Review
Project Number:
PC0263-000
Tumour Type:
Gynecology
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Jemperli (dostarlimab for injection) is indicated as: monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced 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:
Jemperli (dostarlimab for injection) is indicated as: monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum containing regimen.
Recommendation Type:
Do not reimburse
Final Recommendation:
  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 openSeptember 09, 2021
Call for patient/clinician input closedOctober 29, 2021
Submission receivedOctober 07, 2021
Submission acceptedOctober 22, 2021
Review initiatedOctober 25, 2021
Draft CADTH review report(s) provided to sponsor for commentJanuary 21, 2022
Deadline for sponsors commentsFebruary 01, 2022
CADTH review report(s) and responses to comments provided to sponsorFebruary 25, 2022
Expert committee meeting (initial)March 09, 2022
Draft recommendation issued to sponsorMarch 23, 2022
Draft recommendation posted for stakeholder feedbackMarch 31, 2022
End of feedback periodApril 14, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingAugust 10, 2022
Final recommendation postedSeptember 12, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)September 08, 2022
CADTH review report(s) postedNovember 25, 2022