Tag Archives: Bristol-Myers Squibb—

April 2022—The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) in combination with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting. The treatment is approved regardless of PD-L1 status and is based on the CheckMate -816 trial, the first positive phase three trial of an immunotherapy-based combination used before surgery for resectable NSCLC.

March 9, 2022—The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) in combination with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting.

July 2020—The Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb) plus ipilimumab (Yervoy, Bristol-Myers Squibb) and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations. Efficacy was investigated in CHECKMATE-9LA, a randomized, open-label trial for patients with metastatic or recurrent NSCLC. Patients were randomized to receive either the combination of nivolumab plus ipilimumab and two cycles of platinum-doublet chemotherapy (n = 361) or platinum-doublet chemotherapy for four cycles (n = 358). The trial demonstrated a statistically significant benefit in overall survival for patients treated with nivolumab plus ipilimumab plus chemotherapy compared with those who received chemotherapy. Median overall survival was 14.1 months (95 percent CI: 13.2, 16.2) versus 10.7 months (95 percent CI: 9.5, 12.5), (HR 0.69; 96.71 percent CI: 0.55, 0.87).

June 5, 2020—The Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb) plus ipilimumab (Yervoy, BMS)

July 13, 2018—The FDA granted accelerated approval to ipilimumab (Yervoy, Bristol-Myers Squibb) for use in combination with nivolumab (Opdivo, BMS) for the treatment of patients 12 years and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.