Bristol-Myers Squibb(BMY) ZACKS·2025-04-09 18:45Core Viewpoint - Bristol Myers Squibb (BMY) has received FDA approval for the label expansion of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adult and pediatric patients aged 12 years and older [1][2] Company Developments - The latest FDA approval converts the previous accelerated approval for Opdivo monotherapy in the second-line setting to full approval and expands the indication for Opdivo plus Yervoy into the first-line treatment [2] - The approval was based on the phase III CheckMate-8HW study, which showed that Opdivo plus Yervoy met the dual primary endpoints of progression-free survival compared to Opdivo monotherapy and chemotherapy [4][5] - Opdivo plus Yervoy demonstrated a 79% reduction in the risk of disease progression or death compared to chemotherapy in the first-line setting and a 38% reduction versus Opdivo monotherapy across all lines of therapy [5] - The approval was granted more than two months ahead of the target action date of June 23, 2025, with ongoing studies assessing various secondary endpoints, including overall survival [6] Market Performance - BMY shares have increased by 7.9% over the past year, contrasting with a 20% decline in the industry [3] Portfolio Expansion - The approval of Opdivo continues to enhance BMY's immuno-oncology portfolio, with expectations for sustained impact into the next decade [7] - BMY's growth portfolio, which includes drugs like Reblozyl, Breyanzi, Camzyos, and Opdualag, has stabilized revenue amid generic competition for legacy drugs [10] - The company has also recently acquired 2seventy bio, Inc. for $286 million, sharing profits and losses related to the development of Abecma in the U.S. [12]