Last Updated : April 17, 2025
Details
FilesGeneric Name:
inavolisib
Project Status:
Active
Therapeutic Area:
Advanced or metastatic breast cancer
Manufacturer:
Hoffmann-La Roche Limited
Call for patient/clinician input open:
Brand Name:
Itovebi
Project Line:
Reimbursement Review
Project Number:
PC0382-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Inavolisib in combination with a CDK4/6 inhibitor and fulvestrant for the treatment of adult patients with endocrine resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine treatment.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Inavolisib in combination with palbociclib and fulvestrant is indicated for the treatment of adult patients with endocrine resistant, PIK3CA-mutated, hormone receptor-positive (HR+) (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine treatment.
- 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 08, 2025 |
|---|---|
| Call for patient/clinician input closed | March 03, 2025 |
| Submission received | February 19, 2025 |
| Submission accepted | March 05, 2025 |
| Review initiated | March 06, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | May 23, 2025 |
| Deadline for sponsors comments | June 03, 2025 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | June 26, 2025 |
| Expert committee meeting (initial) | July 09, 2025 |
| Draft recommendation issued to sponsor | July 21, 2025 To July 23, 2025 |
| Draft recommendation posted for stakeholder feedback | July 31, 2025 |
| End of feedback period | August 15, 2025 |
Files
Last Updated : April 17, 2025