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| Project Number | pCODR 10218 |
|---|---|
| Brand Name | Opdivo in combination with Yervoy |
| Generic Name | Nivolumab in combination with Ipilimumab |
| Strength | 10 mg/mL |
| Tumour Type | Lung |
| Indication | Non-Small Cell Lung Cancer (NSCLC) |
| Funding Request | Nivolumab, in combination with ipilimumab and 2 cycles of platinum-based chemotherapy for the first-line treatment of patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | August 6, 2020 |
| Manufacturer | Bristol-Myers Squibb |
| Sponsor | Bristol-Myers Squibb |
| Submission Date | June 23, 2020 |
| Submission Deemed Complete | July 8, 2020 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | July 8, 2020 |
| Check-point meeting | September 23, 2020 |
| pERC Meeting (target date) | |
| Initial Recommendation Issued (target date) | |
| Feedback Deadline (target date) ‡ | |
| 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.