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Nivolumab, sold under the brand name Opdivo, is an anti-cancer medication used to treat a number of types of cancer. [2] This includes melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal ...
Nivolumab/relatlimab, sold under the brand name Opdualag, is a fixed-dose combination medication use to treat melanoma. [10] It contains nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody. [10]
Bristol Myers' (BMY) Opdivo gets label expansion in the United States for adjuvant treatment of patients with high-risk urothelial carcinoma.
* Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).
Bristol-Myers Squibb has received approval from the US Food and Drug Administration for Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy to treat gastric cancer ...
It was approved in 2014. Nivolumab is approved to treat melanoma, lung cancer, kidney cancer, bladder cancer, head and neck cancer, and Hodgkin's lymphoma. [16] Pembrolizumab (brand name Keytruda) is another PD-1 inhibitor that was approved by the FDA in 2014 and was the second checkpoint inhibitor approved in the United States. [17]
In October 2020, the U.S. FDA approved the combination of nivolumab with ipilimumab for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. [32] This is the first drug regimen approved for mesothelioma in sixteen years and the second FDA-approved systemic therapy for mesothelioma. [32]
The results of the testing program are codified in an FDA-approved public document that is called the product label, package insert or Full Prescribing Information. [10] The prescribing information is widely available on the web from the FDA, [11] drug manufacturers, and frequently inserted into drug packages. The main purpose of a drug label ...