Last Updated : April 17, 2025
Details
FilesGeneric Name:
abemaciclib
Project Status:
Active
Therapeutic Area:
HR-positive, HER2-negative advanced or metastatic breast cancer
Manufacturer:
Eli Lilly Canada Inc.
Call for patient/clinician input open:
Brand Name:
Verzenio
Project Line:
Reimbursement Review
Project Number:
PC0409-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of hormone receptor HR-positive, HER2-negative advanced or metastatic breast cancer. in combination with an aromatase inhibitor in postmenopausal women as initial endocrine-based therapy. in combination with fulvestrant in women with disease progression following endocrine therapy. Pre- or perimenopausal women must also be treated with a GnRH agonist.
Submission Type:
Reassessment
Fee Schedule:
Schedule A
Indications:
Verzenio (abemaciclib) (tablets) is indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer as follows: • in combination with an aromatase inhibitor in postmenopausal women as initial endocrine-based therapy. • in combination with fulvestrant in women with disease progression following endocrine therapy. Pre- or perimenopausal women must also be treated with a gonadotropin-releasing hormone (GnRH) agonist. • as a single agent in women with disease progression following endocrine therapy and at least 2 prior chemotherapy regimens. At least one chemotherapy...
- 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 | 14-Feb-25 |
| Submission accepted | 11-Mar-25 |
| Clarification: - Submission was not accepted for review on 03 Mar 2025 | |
| Review initiated | 12-Mar-25 |
| Draft CADTH review report(s) provided to sponsor for comment | 26-May-25 |
| Deadline for sponsors comments | 04-Jun-25 |
| CDA-AMC 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 |
Files
Last Updated : April 17, 2025