Last Updated : July 9, 2024
Details
Generic Name:
capivasertib
Project Status:
Active
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:
Schedule A
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.
- 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.
| Call for patient/clinician input open | 03-Jan-24 |
|---|---|
| Call for patient/clinician input closed | 26-Feb-24 |
| Clarification: - Patient input submission received from Canadian Breast Cancer Network and Rethink Breast Cancer | |
| Submission received | 14-Feb-24 |
| Submission accepted | 29-Feb-24 |
| Review initiated | 01-Mar-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 27-May-24 |
| Deadline for sponsors comments | 05-Jun-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 27-Jun-24 |
| Expert committee meeting (initial) | 10-Jul-24 |
| Draft recommendation issued to sponsor | July 22, 2024 To July 24, 2024 |
| Draft recommendation posted for stakeholder feedback | 01-Aug-24 |
| End of feedback period | 16-Aug-24 |
Last Updated : July 9, 2024