Tag Archives: Opdivo

Bristol Myers, yielding to FDA pressure, pulls Opdivo in post-Nexavar liver cancer

Amid a regulatory campaign targeting immuno-oncology agents, Bristol Myers Squibb figured it’s probably futile to keep fighting the FDA on Opdivo’s shaky use in previously treated liver cancer. On Friday, Bristol Myers said it’s voluntarily withdrawing Opdivo’s approval in hepatocellular carcinoma patients who previously received Bayer’s standard-of-care Nexavar. The decision came about three months after… Read More »

FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma

PRINCETON, N.J.–(BUSINESS WIRE) October 2, 2020 — Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural… Read More »

Bristol Myers Squibb’s Opdivo cuts relapse risk in muscle-invasive bladder cancer

Bristol Myers Squibb’s Opdivo has plenty of competition in its current bladder cancer indication—so it’s hoping to strike out on its own in a new area of the disease. The company revealed Thursday that its PD-1 fighter, against placebo, had lengthened the time muscle-invasive urothelial carcinoma patients could remain disease-free after surgery. All patients saw benefit,… Read More »

FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine- and Platinum-based Chemotherapy

Print this page PRINCETON, N.J.–(BUSINESS WIRE) June 10, 2020 Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.1 This application was granted… Read More »