U.S. License Holder:
Bristol-Myers Squibb
Date of License:
December-27-2024
Last Update:
Dec-15-2025
FDA-Approved Indications
OPDIVO QVANTIG (nivolumab; hyaluronidase-nvhy) is a combination of nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of:
Renal Cell Carcinoma (RCC): Adult patients with intermediate or poor risk advanced RCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab; Adult patients with advanced RCC, as a first-line treatment in combination with cabozantinib; Adult patients with advanced RCC who have received prior anti-angiogenic therapy;
Melanoma: Adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic melanoma; Adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic melanoma following combination treatment with intravenous nivolumab and ipilimumab; For the adjuvant treatment of adult and pediatric (12 years and older who weigh 30 kg or greater) patients 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) NSCLC 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) NSCLC and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by OPDIVO QVANTIG monotherapy as adjuvant treatment after surgery; Adult patients with metastatic NSCLC 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 QVANTIG;
Squamous Cell Carcinoma of the Head and Neck (SCCHN): Adult patients with recurrent or metastatic SCCHN with disease progression on or after a platinum-based therapy;
Urothelial Carcinoma: Adjuvant treatment of adult patients with 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 who weigh 30 kg or greater) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC), following combination treatment with intravenous nivolumab and ipilimumab; Adult and pediatric (12 years and older who weigh 30 kg or greater) patients with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan;
Hepatocellular Carcinoma (HCC): Adult patients with unresectable or metastatic HCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab; Adult patients with unresectable or metastatic HCC, who have been previously treated with sorafenib following combination treatment with intravenous nivolumab and 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 (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy, whose tumors express PD-L1 (greater than or equal to 1); Adult patients with unresectable advanced, recurrent or metastatic 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 whose tumors express PD-L1 (greater than or equal to 1) in combination with fluoropyrimidine- and platinum-containing chemotherapy.