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Trastuzumab Emtansine (Kadcyla) for Early Breast Cancer (EBC) — Details

Project Number pCODR 10182
Brand Name Kadcyla
Generic Name Trastuzumab Emtansine
Tumour Type Breast
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 Under Review
Pre Noc Submission Yes
NOC Date
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
Prioritization Requested
Stakeholder Input Deadline ‡ July 16, 2019
Check-point meeting (target date) August 28, 2019
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
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.