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Trastuzumab emtansine for Metastatic Breast Cancer - Details

Project Number pCODR 10024
Brand Name Kadcyla
Generic Name Trastuzumab emtansine
Strength 100mg and 160 mg vial
Tumour Type Breast
Indication Metastatic Breast Cancer
Funding Request The treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab and a taxane
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date September 11, 2013
Manufacturer Hoffman-La Roche Ltd.
Submitter Hoffman-La Roche Ltd.
Submission Date March 15, 2013
Submission Deemed Complete March 22, 2013
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ April 2, 2013
Check-point meeting July 25, 2013
pERC Meeting October 17, 2013
Initial Recommendation Issued October 31, 2013
Feedback Deadline ‡ November 15, 2013
pERC Reconsideration Meeting December 19, 2013
Final Recommendation Issued January 10, 2014
Notification to Implement Issued January 27, 2014
Clarification A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.

‡ 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.