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|Project Number||pCODR 10182|
|Generic Name||Trastuzumab Emtansine|
|Strength||100 mg and 160 mg vial|
|Indication||Early Breast Cancer (EBC)|
|Funding Request||For the adjuvant treatment of patients with HER2-positive early breast cancer, who have residual disease, after pre-operative systemic treatment. KADCYLA should be continued for 14 cycles or until disease progression or unacceptable toxicity. If KADCYLA is discontinued in the event of toxicity, treatment with trastuzumab may be continued to complete one year of HER2-directed therapy.|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||November 25, 2019|
|Manufacturer||Hoffmann-La Roche Limited|
|Sponsor||Hoffmann-La Roche Limited|
|Submission Date||July 2, 2019|
|Submission Deemed Complete||July 16, 2019|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||July 16, 2019|
|Check-point meeting||August 28, 2019|
|pERC Meeting||December 12, 2019|
|Initial Recommendation Issued||January 3, 2020|
|Feedback Deadline ‡||January 17, 2020|
|pERC Reconsideration Meeting (target date)|
|Final Recommendation Issued||January 22, 2020|
|Notification to Implement Issued||February 6, 2020|
‡ 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.