Last Updated : November 28, 2022
Details
FilesGeneric 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
Performance Metric:
Achieved
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:
- 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 open | September 09, 2021 |
| Call for patient/clinician input closed | October 29, 2021 |
| Submission received | October 07, 2021 |
| Submission accepted | October 22, 2021 |
| Review initiated | October 25, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | January 21, 2022 |
| Deadline for sponsors comments | February 01, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | February 25, 2022 |
| Expert committee meeting (initial) | March 09, 2022 |
| Draft recommendation issued to sponsor | March 23, 2022 |
| Draft recommendation posted for stakeholder feedback | March 31, 2022 |
| End of feedback period | April 14, 2022 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | August 10, 2022 |
| Final recommendation posted | September 12, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | September 08, 2022 |
| CADTH review report(s) posted | November 25, 2022 |
Files
Last Updated : November 28, 2022