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| Project Number | PC0218-000 |
|---|---|
| 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 | Notification to Implement Issued |
| 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 | Initial |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | July 8, 2020 |
| Check-point meeting | September 23, 2020 |
| pERC Meeting | December 17, 2020 |
| Initial Recommendation Issued | January 8, 2021 |
| Feedback Deadline ‡ | January 22, 2021 |
| pERC Reconsideration Meeting | February 18, 2021 |
| Final Recommendation Issued | March 4, 2021 |
| Notification to Implement Issued | March 19, 2021 |
| Therapeutic Area | NSCLC |
‡ 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.
