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Nivolumab-Ipilimumab for Non-Small Cell Lung Cancer - Details

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.