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Opdivo for Melanoma Adjuvant Therapy – Details

Project Number pCODR 10147
Brand Name Opdivo
Generic Name Nivolumab
Strength 40 mg & 100 mg
Tumour Type Skin & Melanoma
Indication Melanoma Adjuvant Therapy
Funding Request For the adjuvant treatment of adult patients after complete resection of melanoma with regional lymph node involvement, in transit metastases/satellites without metastatic nodes, or distant metastases
Review Status Under Review
Pre Noc Submission Yes
NOC Date November 15, 2018
Manufacturer Bristol-Myers Squibb Canada
Submitter Bristol-Myers Squibb Canada
Submission Date August 27, 2018
Submission Deemed Complete September 11, 2018
Submission Type New Indication
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ September 11, 2018
Check-point meeting October 17, 2018
pERC Meeting December 13, 2018
Initial Recommendation Issued (target date) January 4, 2019
Feedback Deadline (target date) ‡ January 18, 2019
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ 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.