Last Updated : November 7, 2024
Details
Generic Name:
ribociclib
Project Status:
Pending
Therapeutic Area:
Adjuvant treatment of HR-positive, HER2-negative early breast cancer
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Kisqali
Project Line:
Reimbursement Review
Project Number:
PC0395-000
Call for patient/clinician input closed:
Tumour Type:
Breast
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ribociclib is indicated: • for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer (eBC), in combination with an aromatase inhibitor (AI). • in pre- or perimenopausal women, or men, the AI should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
Submission Type:
Initial
Fee Schedule:
Pending
Indications:
Ribociclib is indicated: • for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer (eBC), in combination with an aromatase inhibitor (AI). • in pre- or perimenopausal women, or men, the AI should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
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 : November 7, 2024