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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
Tumour Type Breast
Indication Early Breast Cancer
Funding Request For 18 cycles for the 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 Pending
Pre Noc Submission Yes
NOC Date
Manufacturer Hoffmann-La Roche Limited
Submitter Hoffmann-La Roche Limited
Submission Date (Target Date) April 9, 2018
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ April 23, 2018
Check-point meeting (target date)
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.