sacituzumab govitecan

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Generic 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:
  1. 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 openJune 02, 2021
Call for patient/clinician input closedJuly 23, 2021
Clarification:

- Patient input submission received from Canadian Breast Cancer Network, and Rethink Breast Cancer.

Submission receivedJune 30, 2021
Submission acceptedJuly 15, 2021
Review initiatedJuly 16, 2021
Draft CADTH review report(s) provided to sponsor for commentOctober 07, 2021
Deadline for sponsors commentsOctober 19, 2021
CADTH review report(s) and responses to comments provided to sponsorNovember 19, 2021
Expert committee meeting (initial)December 01, 2021
Draft recommendation issued to sponsorDecember 14, 2021
Draft recommendation posted for stakeholder feedbackDecember 23, 2021
End of feedback periodJanuary 14, 2022
Final recommendation issued to sponsor and drug plansJanuary 27, 2022
Final recommendation postedFebruary 11, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 10, 2022
CADTH review report(s) postedApril 08, 2022