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Abraxane for Metastatic Pancreatic Cancer - Details

Project Number pCODR 10037
Brand Name Abraxane
Generic Name Nab-paclitaxel
Strength 100 mg/vial
Tumour Type Gastrointestinal
Indication Metastatic Pancreatic Cancer
Funding Request For the first line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date July 16, 2014
Manufacturer Celgene Inc.
Submitter Celgene Inc.
Submission Date February 14, 2014
Submission Deemed Complete February 24, 2014
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ March 3, 2014
Check-point meeting April 30, 2014
pERC Meeting August 21, 2014
Initial Recommendation Issued September 5, 2014
Feedback Deadline ‡ September 19, 2014
Final Recommendation Issued September 23, 2014
Notification to Implement Issued October 8, 2014
Clarification A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.

‡ 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.