Last Updated : April 25, 2024
Details
FilesGeneric Name:
dostarlimab
Project Status:
Active
Therapeutic Area:
Endometrial cancer
Manufacturer:
GlaxoSmithKline Inc.
Call for patient/clinician input open:
Brand Name:
Jemperli
Project Line:
Reimbursement Review
Project Number:
PC0325-000
Call for patient/clinician input closed:
Tumour Type:
Gynecology
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Jemperli (dostarlimab for injection) is indicated: in combination with platinum-containing chemotherapy for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Jemperli (dostarlimab for injection) is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy.
- 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.
| Call for patient/clinician input open | September 05, 2023 |
|---|---|
| Call for patient/clinician input closed | October 30, 2023 |
| Clarification: - No patient input submission received | |
| Submission received | October 18, 2023 |
| Submission accepted | November 01, 2023 |
| Review initiated | November 02, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | January 29, 2024 |
| Deadline for sponsors comments | February 07, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | March 01, 2024 |
| Expert committee meeting (initial) | March 13, 2024 |
| Draft recommendation issued to sponsor | March 27, 2024 |
| Draft recommendation posted for stakeholder feedback | April 04, 2024 |
| End of feedback period | April 18, 2024 |
| Final recommendation issued to sponsor and drug plans | May 03, 2024 |
| Final recommendation posted | - |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 17, 2024 |
| CADTH review report(s) posted | - |
Files
Last Updated : April 25, 2024