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

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.