Bristol-Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a strong focus on oncology, immunology, cardiology, and fibrotic diseases, the company utilizes advanced science and research to create life-changing therapies. Bristol-Myers Squibb emphasizes collaboration and partnerships with healthcare professionals, researchers, and patients to enhance treatment outcomes and improve quality of life. The company is committed to addressing unmet medical needs through its comprehensive portfolio of prescription medications and is actively engaged in ongoing research to advance healthcare solutions. Read More
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most common primary liver cancer.1,2 This approval is based on the results from the global Phase 3 randomized, open-label CheckMate-9DW trial evaluating the combination of Opdivo plus Yervoy compared to investigator’s choice of tyrosine kinase inhibitor monotherapy (lenvatinib or sorafenib) in patients with unresectable or metastatic HCC who have not received prior systemic therapy.1 In the trial, Opdivo plus Yervoy demonstrated statistically significant overall survival (OS) and overall response rate (ORR) vs the comparator arm.1 It is the only trial supporting an FDA approval to show superior results against this comparator arm.1
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The FDA has approved Opdivo plus Yervoy for the first-line treatment of MSI-H/dMMR colorectal cancer, supported by the Phase 3 CheckMate-8HW trial results.
U.S. District Judge Edgardo Ramos in Manhattan said the plaintiffs failed to show that Bristol Myers and Celgene Corp violated the federal Sherman antitrust law.
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).1 This approval is based on the CheckMate-8HW trial, which is the largest Phase 3 trial (n=839) of immunotherapy in patients with MSI-H/dMMR mCRC, evaluating Opdivo plus Yervoy (n=354) vs. Opdivo monotherapy (n=353) in the all-lines setting and Opdivo plus Yervoy (n=202) vs. investigator’s choice chemotherapy (n=101) (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in the first-line setting.1 Opdivo plus Yervoy met the dual primary endpoints of progression free survival (PFS) when compared to Opdivo monotherapy across all lines of therapy and when compared to chemotherapy in the first-line setting, as assessed by Blinded Independent Central Review (BICR).1 This approval, granted more than two months ahead of the June 23, 2025 Prescription Drug User Fee Act goal date, follows the FDA’s prior decision to grant the application Breakthrough Therapy Designation and Priority Review status.
Bristol-Myers Squibb Co. traces its corporate beginnings back to 1887. Today, the company is a leader in developing innovative drugs like Eliquis for stroke prevention and Opdivo for cancer immunotherapy.
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