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|Project Number||pCODR 10161|
|Strength||50 mg, 100 mg, 150 mg and 200 mg|
|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||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||April 5, 2019|
|Manufacturer||Eli Lilly Canada Inc.|
|Sponsor||Eli Lilly Canada Inc.|
|Submission Date||December 3, 2018|
|Submission Deemed Complete||December 17, 2018|
|Submission Type||New Drug|
|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||June 20, 2019|
|Final Recommendation Issued||July 5, 2019|
|Notification to Implement Issued||July 22, 2019|
‡ 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.