Last Updated : January 29, 2025
Details
FilesGeneric Name:
sacituzumab govitecan
Project Status:
Complete
Therapeutic Area:
Locally advanced or metastatic triple-negative breast cancer
Manufacturer:
Gilead Sciences Canada, Inc.
Brand Name:
Trodelvy
Project Line:
Reimbursement Review
Project Number:
PC0254-000
Tumour Type:
Breast
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior therapies, at least one of them for metastatic disease.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Breast
Indications:
For the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior therapies, at least one of them for metastatic disease.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation/Report:
- 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.
| Call for patient/clinician input open | June 02, 2021 |
|---|---|
| Call for patient/clinician input closed | July 23, 2021 |
| Clarification: - Patient input submission received from Canadian Breast Cancer Network, and Rethink Breast Cancer. | |
| Submission received | June 30, 2021 |
| Submission accepted | July 15, 2021 |
| Review initiated | July 16, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | October 07, 2021 |
| Deadline for sponsors comments | October 19, 2021 |
| CADTH review report(s) and responses to comments provided to sponsor | November 19, 2021 |
| Expert committee meeting (initial) | December 01, 2021 |
| Draft recommendation issued to sponsor | December 14, 2021 |
| Draft recommendation posted for stakeholder feedback | December 23, 2021 |
| End of feedback period | January 14, 2022 |
| Final recommendation issued to sponsor and drug plans | January 27, 2022 |
| Final recommendation posted | February 11, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 10, 2022 |
| CADTH review report(s) posted | April 08, 2022 |
Files
Last Updated : January 29, 2025