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| 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. |
| Sponsor | 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.
