Last Updated : January 6, 2025
Details
FilesGeneric Name:
capivasertib
Project Status:
Complete
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
Performance Metric:
Achieved
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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.
| Call for patient/clinician input open | January 03, 2024 |
|---|---|
| Call for patient/clinician input closed | February 26, 2024 |
| Clarification: - Patient input submission received from Breast Cancer Canada, Canadian Breast Cancer Network and Rethink Breast Cancer | |
| Submission received | February 14, 2024 |
| Submission accepted | February 29, 2024 |
| Review initiated | March 01, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | May 27, 2024 |
| Deadline for sponsors comments | June 05, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | June 27, 2024 |
| Expert committee meeting (initial) | July 10, 2024 |
| Draft recommendation issued to sponsor | July 23, 2024 |
| Draft recommendation posted for stakeholder feedback | August 01, 2024 |
| End of feedback period | August 16, 2024 |
| Final recommendation issued to sponsor and drug plans | August 30, 2024 |
| Final recommendation posted | September 18, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | September 16, 2024 |
| CADTH review report(s) posted | January 06, 2025 |
Files
Last Updated : January 6, 2025