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Tykerb Letrozole for Metastatic Breast Cancer - Details

Project Number pCODR 10019
Brand Name Tykerb (in combination with Letrozole)
Generic Name Lapatinib
Strength 250 mg
Tumour Type Breast
Indication Metastatic Breast Cancer
Funding Request In combination with letrozole for the treatment of postmenopausal patients with hormone receptor positive metastatic breast cancer, whose tumours overexpress the ErbB2 (HER2) receptor, and who are suitable for endocrine therapy
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date September 30, 2010
Manufacturer GlaxoSmithKline
Submitter GlaxoSmithKline
Submission Date December 14, 2012
Submission Deemed Complete December 21, 2012
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ January 8, 2013
Check-point meeting February 19, 2013
pERC Meeting April 18, 2013
Initial Recommendation Issued May 2, 2013
Feedback Deadline ‡ May 16, 2013
pERC Reconsideration Meeting June 20, 2013
Final Recommendation Issued July 5, 2013
Notification to Implement Issued July 22, 2013

‡ 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.