Abemaciclib for advanced or metastatic Breast Cancer – Details


( Last Updated : July 22, 2019)
Generic Name:
Abemaciclib
Project Status:
Complete
Therapeutic Area:
Metastatic Breast Cancer
Manufacturer:
Eli Lilly Canada Inc.
Brand Name:
Verzenio
Project Line:
Reimbursement Review
Project Number:
PC0161-000
NOC Date:

Details


Strength:
50 mg, 100 mg, 150 mg and 200 mg
Tumour Type:
Breast
Indications:
Advanced or metastatic breast cancer
Funding Request:
For the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (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 gonadotropin-releasing hormone agonist.
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
Eli Lilly Canada Inc.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Funding Request:
For the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (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 gonadotropin-releasing hormone agonist.
pERC Meeting:
Final Recommendation Issued:

Files

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.