Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

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
Performance Metric:
Achieved
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 open02-Jun-21
Call for patient/clinician input closed23-Jul-21
Clarification:

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

Submission received30-Jun-21
Submission accepted15-Jul-21
Review initiated16-Jul-21
Draft Canada's Drug Agency review report(s) provided to sponsor for comment07-Oct-21
Deadline for sponsors comments19-Oct-21
Canada's Drug Agency review report(s) and responses to comments provided to sponsor19-Nov-21
Expert committee meeting (initial)01-Dec-21
Draft recommendation issued to sponsor14-Dec-21
Draft recommendation posted for stakeholder feedback23-Dec-21
End of feedback period14-Jan-22
Final recommendation issued to sponsor and drug plans27-Jan-22
Final recommendation posted11-Feb-22
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)10-Feb-22
Canada's Drug Agency review report(s) posted08-Apr-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submissions View PDF
Last Updated : December 23, 2021