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Perjeta-Herceptin Combo Pack for Early Breast Cancer – Details

Project Number pCODR 10127
Brand Name Perjeta-Herceptin Combo Pack
Generic Name Pertuzumab-Trastuzumab Combo Pack
Strength 420 mg/14 mL
Tumour Type Breast
Indication Early Breast Cancer
Funding Request For 18 cycles for the adjuvant treatment of HER2-positive early breast cancer patients at high risk of recurrence. High risk of recurrence is defined as either node-positive or hormone receptor-negative disease
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date August 30, 2018
Manufacturer Hoffmann-La Roche Limited
Submitter Hoffmann-La Roche Limited
Submission Date April 9, 2018
Submission Deemed Complete April 16, 2018
Submission Type New Indication
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ April 23, 2018
Check-point meeting June 19, 2018
pERC Meeting September 20, 2018
Initial Recommendation Issued October 4, 2018
Feedback Deadline ‡ October 19, 2018
pERC Reconsideration Meeting November 15, 2018
Final Recommendation Issued November 29, 2018
Notification to Implement Issued December 14, 2018

‡ 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.