Last Updated : March 6, 2025
Details
Generic 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 | 08-Jan-25 |
|---|---|
| Call for patient/clinician input closed | 03-Mar-25 |
| Submission received | 19-Feb-25 |
| Submission accepted | 05-Mar-25 |
| Review initiated | 06-Mar-25 |
| Draft CADTH review report(s) provided to sponsor for comment | 23-May-25 |
| Deadline for sponsors comments | 03-Jun-25 |
| CADTH review report(s) and responses to comments provided to sponsor | 26-Jun-25 |
| Expert committee meeting (initial) | 09-Jul-25 |
| Draft recommendation issued to sponsor | July 21, 2025 To July 23, 2025 |
| Draft recommendation posted for stakeholder feedback | 31-Jul-25 |
| End of feedback period | 15-Aug-25 |
Last Updated : March 6, 2025