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Abraxane for Metastatic Pancreatic Cancer - Details

Project Number PC0037-000
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 Complete
Pre Noc Submission Yes
NOC Date July 16, 2014
Manufacturer Celgene Inc.
Sponsor Celgene Inc.
Submission Date February 14, 2014
Submission Deemed Complete February 24, 2014
Submission Type Initial
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.
Therapeutic Area Metastatic Pancreatic Cancer
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.