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Perjeta or Perjeta-Herceptin Combo Pack for Neoadjuvant Breast Cancer - Details

Project Number pCODR 10050
Brand Name Perjeta or Perjeta-Herceptin Combo Pack
Generic Name Pertuzumab
Strength 420 mg /vial
Tumour Type Breast
Indication Neoadjuvant Breast Cancer
Funding Request In combination with trastuzumab and chemotherapy prior to surgery for the treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (>2 cm in diameter or node positive) as part of a complete treatment regimen for early stage breast cancer
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date N/A
Manufacturer Hoffmann-La Roche Limited
Submitter Hoffmann-La Roche Limited
Submission Date December 19, 2014
Submission Deemed Complete January 5, 2015
Submission Type New Indication
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ January 12, 2015
Check-point meeting February 17, 2015
pERC Meeting April 17, 2015
Initial Recommendation Issued April 30, 2015
Clarification Please note that the April pERC meeting was conducted over two days. The original date for the posting of pERC Initial Recommendation remained as April 30, 2015.
Feedback Deadline ‡ May 14, 2015
pERC Reconsideration Meeting July 2, 2015
Clarification Due to the number of items for deliberation, the pERC meeting was conducted over two days. Unable to reach quorum for either day around the target reconsideration meeting date of June 18, 2015, pERC held deliberations for all reconsideration items, including pertuzumab, on July 2, 2015
Final Recommendation Issued July 16, 2015
Notification to Implement Issued July 31, 2015

‡ 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.