U.S. Food and Drug Administration Approves Opdivo® (nivolumab) with Chemotherapy as Neoadjuvant Treatment for Certain Adult Patients with Resectable Non-Small Cell Lung Cancer

Mar 04, 2022

Bristol+Myers+Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo^®(nivolumab) 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) in the neoadjuvant setting.¹ Opdivo plus chemotherapy is approved regardless of PD-L1 status.¹ The approval is based on the CheckMate -816 trial, the first positive Phase 3 trial of an immunotherapy-based combination used before surgery for resectable NSCLC. The primary endpoints included event-free survival (EFS) and pathologic complete response (pCR), which were evaluated using independent blinded review, and an additional efficacy outcome measure was overall survival (OS).¹ The study compared Opdivo plusplatinum-doublet chemotherapy (n=179) to platinum-doublet chemotherapy alone (n=179).¹

Research Tools

All-In-One Screener Stock Ideas Stock List Guru List Guru Real-Time Picks Insider List Insider Trades Economic Indicators Sector & Industry Performance DCF Calculator Discussion Board

Product

Pricing Plans Excel Add-In Google Sheets Add-on Data API Stock Comparison Table Manual of Stocks Mobile App 中文

Education

Financial Glossary Tutorials FAQ Schedule Free Session Buffett Indicator Shiller P/E Yield Curve Today U.S. Inflation Rate Global Market Valuation Fed Net Liquidity Buffett Assets Allocation

Company

About GuruFocus Career Contact Us ETF Advertise Site Map Term of Use Privacy Policy Referral Program Partner Program

Survey

We'd love to learn more about your experiences on GuruFocus.com and how we can improve!

Take Survey

Disclaimers

GuruFocus.com is not operated by a broker or a dealer. It has an affiliated registered investment adviser, which serves as the subadviser to an exchange traded fund. This investment adviser does not provide advice to individual investors. Under no circumstances does any information posted on GuruFocus.com represent a recommendation to buy or sell a security. The information on this site, and in its related newsletters, is not intended to be, nor does it constitute investment advice or recommendations. The individuals or entities selected as "gurus" may buy and sell securities before and after any particular article and report and information herein is published, with respect to the securities discussed in any article and report posted herein. Gurus may be added or dropped from the GuruFocus site at any time. In no event shall GuruFocus.com be liable to any member, guest or third party for any damages of any kind arising out of the use of any content or other material published or available on GuruFocus.com, or relating to the use of, or inability to use, GuruFocus.com or any content, including, without limitation, any investment losses, lost profits, lost opportunity, special, incidental, indirect, consequential or punitive damages. Past performance is a poor indicator of future performance. The information on this site, and in its related newsletters, is not intended to be, nor does it constitute investment advice or recommendations. The information on this site is in no way guaranteed for completeness, accuracy or in any other way. The gurus listed in this website are not affiliated with GuruFocus.com, LLC. Stock quotes are provided by QuoteMedia, Inc. (CSI). Company fundamental data is provided by Morningstar. Analyst estimates data is sourced from both Refinitiv and Morningstar, with priority given to Refinitiv data. Data is updated daily.