Project Number | pCODR 10003 |
---|---|
Brand Name | Yervoy |
Generic Name | Ipilimumab |
Strength | 5 mg/mL |
Tumour Type | Skin and Melanoma |
Indication | Advanced Melanoma |
Funding Request | Treatment of advanced melanoma (unresectable Stage III and IV melanoma) in patients who have received prior systemic therapy |
Review Status | Notification to Implement Issued |
Pre Noc Submission | Yes |
NOC Date | February 1, 2012 |
Manufacturer | Bristol-Myers Squibb Canada |
Sponsor | Bristol-Myers Squibb Canada |
Submission Date | December 1, 2011 |
Submission Deemed Complete | December 7, 2011 |
Submission Type | New Drug |
Prioritization Requested | Not Requested |
Stakeholder Input Deadline ‡ | December 15, 2011 |
Check-point meeting | January 24, 2012 |
pERC Meeting | March 15, 2012 |
Initial Recommendation Issued | March 29, 2012 |
Feedback Deadline ‡ | April 16, 2012 |
Final Recommendation Issued | April 18, 2012 |
Notification to Implement Issued | May 2, 2012 |
‡ 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.