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Abemaciclib for advanced or metastatic Breast Cancer – Details

Project Number pCODR 10161
Brand Name Verzenio
Generic Name Abemaciclib
Strength 50 mg, 100 mg, 150 mg and 200 mg
Tumour Type Breast
Indication 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 Under Review
Pre Noc Submission Yes
NOC Date April 5, 2019
Manufacturer Eli Lilly Canada Inc.
Submitter Eli Lilly Canada Inc.
Submission Date December 3, 2018
Submission Deemed Complete December 17, 2018
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ December 17, 2018
Check-point meeting February 19, 2019
pERC Meeting April 18, 2019
Initial Recommendation Issued May 3, 2019
Feedback Deadline ‡ May 17, 2019
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ 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.