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Opdivo for Metastatic Melanoma - Details

Project Number pCODR 10063
Brand Name Opdivo
Generic Name Nivolumab
Strength 40mg/4mL and 100mg/10mL vials
Tumour Type Skin and Melanoma
Indication Metastatic Melanoma
Funding Request For the treatment of both first-line and previously-treated advanced adult melanoma patients, regardless of BRAF status
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date September 25, 2015
Manufacturer Bristol-Myers Squibb Canada
Submitter Bristol-Myers Squibb Canada
Submission Date August 13, 2015
Submission Deemed Complete September 1, 2015
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ August 27, 2015
Check-point meeting November 18, 2015
pERC Meeting January 21, 2016
Clarification An expanded scope of review has been granted for nivolumab (Opdivo). In accordance with the pCODR Procedures, the pCODR Provincial Advisory Group (PAG) requested additional information on nivolumab (Opdivo) which extends beyond the submitted scope of the review. Revision of review scope may be considered by pCODR in very limited instances, based on jurisdictional input, feasibility to conduct the revised review and clinical importance. All three criteria for scope modification were met in this case. The timeline of the review was temporarily stopped, pending receipt of the additional information. The timeline of the review has resumed as the additional information has now been provided and a new target pERC date has been set by pCODR.
Initial Recommendation Issued February 4, 2016
Feedback Deadline ‡ February 19, 2016
pERC Reconsideration Meeting March 17, 2016
Final Recommendation Issued April 1, 2016
Notification to Implement Issued April 18, 2016

‡ 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.