Dernière mise à jour : 02 septembre 2016
Détails
FichiersGeneric Name:
Regorafenib
État du projet:
Terminé
Domaine thérapeutique:
Metastatic Colorectal Cancer
Fabricant:
Bayer Inc.
Brand Name:
Stivarga Resubmission (CRC)
Gamme de produits:
Examen en vue du remboursement
Numéro de projet :
PC0046-000
Strength:
40mg tablet
Tumour Type:
Gastrointestinal
Indications:
Metastatic Colorectal Cancer
Funding Request:
Treatment of patients with metastatic colorectal cancer (CRC), and an ECOG status of ≤1, who have been previously treated with fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy
Review Status:
Complete
Date NOC Issued:
Sponsor:
Bayer Inc.
Submission Date:
Submission Deemed Complete:
Priorisation demandée:
Non demandée
Stakeholder Input Deadline ‡:
Check-point meeting:
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 the regorafenib resubmission, on July 2, 2015
pERC Meeting:
pERC Meeting (target date):
Final Recommendation Issued:
Fichiers
‡ 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.
Dernière mise à jour : 02 septembre 2016