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Cyramza for Advanced GC or GEJ Adenocarcinoma – Details

Project Number pCODR 10059
Brand Name Cyramza
Generic Name Ramucirumab
Strength 10 mg/mL
Tumour Type Gastrointestinal
Indication Metastatic Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma
Funding Request As a single agent or in combination with paclitaxel for the treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma after prior chemotherapy
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date July 16, 2015
Manufacturer Eli Lilly Canada Inc.
Submitter Eli Lilly Canada Inc.
Submission Date April 15, 2015
Submission Deemed Complete April 22, 2015
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ April 29, 2015
Check-point meeting June 5, 2015
pERC Meeting August 20, 2015
Initial Recommendation Issued September 3, 2015
Feedback Deadline ‡ September 18, 2015
pERC Reconsideration Meeting October 15, 2015
Final Recommendation Issued October 29, 2015
Notification to Implement Issued November 13, 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.