U.S. License Holder:
Bristol-Myers Squibb
Date of License:
December-22-2014 [March-04-2015]
Last Update:
Nov-15-2024
FDA-Approved Indications
BL 125554: OPDIVO (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of:
Melanoma: Adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab; For the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma;
Non-Small Cell Lung Cancer (NSCLC): Adult patients with resectable (tumors greater than or equal to 4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy; Adult patients with resectable (tumors greater than or equal to 4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery; Adult patients with metastatic non-small cell lung cancer expressing PD-L1 (greater than or equal to 1 percent) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab; Adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy; Adult patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo;
Malignant Pleural Mesothelioma: Adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab;
Renal Cell Carcinoma (RCC): Adult patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab; Adult patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib; Adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy;
Classical Hodgkin Lymphoma (cHL): Adult patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT;
Squamous Cell Carcinoma of the Head and Neck (SCCHN): Adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy;
Urothelial Carcinoma: Adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC; Adult patients with unresectable or metastatic urothelial carcinoma, as firstline treatment in combination with cisplatin and gemcitabine; Adult patients with locally advanced or metastatic urothelial carcinoma who: have disease progression during or following platinum-containing chemotherapy; have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy;
Colorectal Cancer: Adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan as a single agent or in combination with ipilimumab;
Hepatocellular Carcinoma (HCC): Adult patients with hepatocellular carcinoma who have been previously treated with sorafenib in combination with ipilimumab;
Esophageal Cancer: Adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT); Adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy; Adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab; Adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine-and platinum-based chemotherapy;
Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma: Adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy.
BL 125527: OPDIVO (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with:
Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor;
Metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.
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