FDA approves neoadjuvant/adjuvant nivolumab for resectable …
WEB23 hours ago · Patients were randomized (1:1) to either nivolumab or placebo, with platinum-based chemotherapy, every 3 weeks for up to 4 cycles (neoadjuvant treatment) followed by either continued single-agent ...
Perioperative Opdivo Extends Event-Free Survival in Lung Cancer
WEB10 hours ago · Patients with resectable (surgically unremovable) non-small cell lung cancer (NSCLC) undergoing treatment with perioperative Opdivo (nivolumab) demonstrated extended event-free survival (EFS; living without complications or disease worsening) versus placebo, according to findings from a phase 3 trial.
Neoadjuvant/Adjuvant Opdivo Approved for Resectable NSCLC
WEB4 hours ago · Findings showed treatment with nivolumab reduced the risk of disease recurrence, progression or death by 42% compared with placebo (EFS hazard ratio [HR], 0.58; 95% CI, 0.43-0.78; P =.00025 ...
Nivolumab NSCLC Approval Expanded to Perioperative Setting
WEB4 hours ago · Safety was comparable to that seen in other clinical trials of nivolumab plus chemotherapy; 5.3% and 3.5% of patients in the nivolumab and placebo arms, respectively, were unable to undergo ...
FDA Approves Perioperative Nivolumab for Resectable NSCLC
WEB8 hours ago · Similarly, patients without a pCR in the nivolumab arm (n = 98) also experienced an EFS benefit compared with those who received placebo and did not achieve a pCR (n = 148; HR, 0.75; 95% CI, 0.51 ...
U.S. Food and Drug Administration Approves Opdivo®(nivolumab…
WEBOct 13, 2023 · PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo ® (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing …
FDA approves nivolumab in combination with cisplatin and …
WEBOn March 6, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult...
Bristol Myers Squibb - U.S. Food and Drug Administration Accepts ...
WEBMay 6, 2024 · Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor. The FDA assigned a target action date of February 28, 2025.
FDA approves nivolumab for adjuvant treatment of Stage IIB/C …
WEBOn October 13, 2023, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for the adjuvant treatment of completely resected Stage IIB/C melanoma in...
Researchers build first large-scale atlas of how immune cells react …
WEB2 days ago · More information: Tyler J. Alban et al, Neoantigen immunogenicity landscapes and evolution of tumor ecosystems during immunotherapy with nivolumab, Nature Medicine (2024). DOI: 10.1038/s41591-024 ...