Last Updated : January 9, 2025
Details
Generic Name:
inavolisib
Project Status:
Pending
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
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Inavolisib in combination with a CDK4/6 inhibitor and fulvestrant for the treatment of adult patients with 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
Fee Schedule:
Pending
Indications:
Inavolisib in combination with palbociclib and fulvestrant is indicated for the treatment of adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
Anticipated Date:
- 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.
Last Updated : January 9, 2025