capivasertib

Details

Generic Name:
capivasertib
Project Status:
Received
Therapeutic Area:
HR-positive, HER2-negative locally advanced or metastatic breast cancer
Manufacturer:
AstraZeneca Canada Inc
Call for patient/clinician input open:
Brand Name:
Truqap
Project Line:
Reimbursement Review
Project Number:
PC0341-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Pending
Indications:
​For the treatment of adult females with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
  1. 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.
Key Milestones2
Call for patient/clinician input openJanuary 03, 2024
Call for patient/clinician input closedFebruary 26, 2024
Submission receivedFebruary 14, 2024
Submission accepted-