Checkmate 9la study design9/6/2023 Autoimmune diabetes similar to diabetes mellitus type 1 may occur in approximately 2% of people treated with nivolumab. Hypothyroidism may affect 8.5% and hyperthyroidism 3.7%. The drug label contains warnings with regard to increased risks of severe immune-mediated inflammation of the lungs, the colon, the liver, the kidneys (with accompanying kidney dysfunction), as well as immune-mediated hypothyroidism and hyperthyroidism. FDA expanded the indication to include the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). FDA approved nivolumab for the adjuvant treatment of people with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. FDA approved nivolumab for people with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. Food and Drug Administration (FDA) approved nivolumab, in combination with certain types of chemotherapy, for the initial treatment of people with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. The combination of nivolumab with ipilimumab is used for the first-line treatment of adults with malignant pleural mesothelioma (MPM) that cannot be removed by surgery. Nivolumab is indicated for the adjuvant treatment of people with melanoma with involvement of lymph nodes or in people with metastatic disease who have undergone complete resection. It can be prescribed for locally advanced or metastatic form of the condition that experience disease progression during or following platinum-containing chemotherapy or have progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Nivolumab is used for primary or metastatic urothelial carcinoma, the most common form of bladder cancer. It is also used to treat metastatic squamous non-small cell lung cancer with progression with or after platinum-based drugs and for treatment of small cell lung cancer It also used as a second-line treatment for renal cell carcinoma after anti-angiogenic treatment has failed. Nivolumab is used as a first-line treatment for inoperable or metastatic melanoma in combination with ipilimumab if the cancer does not have a mutation in BRAF, and as a second-line treatment for inoperable or metastatic melanoma following treatment of ipilimumab and, if the cancer has a BRAF mutation, a BRAF inhibitor.
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