U.S. License Holder:

Bristol-Myers Squibb

Date of License:

December-27-2024

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 patients with unresectable or metastatic melanoma; Adult patients with unresectable or metastatic melanoma following combination treatment with intravenous nivolumab and ipilimumab; For the adjuvant treatment of adult 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 patients with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan as monotherapy or as monotherapy following combination treatment with intravenous nivolumab and ipilimumab;

Hepatocellular Carcinoma (HCC): Adult patients with HCC who have been previously treated with sorafenib and 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 as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy; 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.