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

trastuzumab deruxtecan

Details

Generic Name:
trastuzumab deruxtecan
Project Status:
Pending
Therapeutic Area:
HER2-low or HER2-ultralow breast cancer
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Enhertu
Project Line:
Reimbursement Review
Project Number:
PC0401-000
Call for patient/clinician input closed:
Tumour Type:
Breast
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of therapy.
Submission Type:
Initial
Fee Schedule:
Pending
Indications:
For the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting.
Anticipated Date:
  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.
Last Updated : April 2, 2025