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

Détails

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Generic Name:
Pertuzumab
État du projet:
Terminé
Domaine thérapeutique:
Neoadjuvant Breast Cancer
Fabricant:
Hoffmann-La Roche Limited
Brand Name:
Perjeta or Perjeta-Herceptin Combo Pack
Gamme de produits:
Examen en vue du remboursement
Numéro de projet :
PC0050-000
Indicateur de rendement:
S. O. – Mesures de rendement prédictives
Strength:
420 mg /vial
Tumour Type:
Breast
Indications:
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:
Complete
Pre Noc Submission:
Yes
Date NOC Issued:
Sponsor:
Hoffmann-La Roche Limited
Submission Date:
Submission Deemed Complete:
Priorisation demandée:
Demandée et refusée
Stakeholder Input Deadline ‡:
Check-point meeting:
Check-point meeting (target date):
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommandation:
Ne pas rembourser
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.
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
pERC Meeting:
Final Recommendation 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.