OPDIVO- nivolumab injection

Bristol Myers Squibb

OPDIVO 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. (1.1)
• 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. (1.2)

Non-Small Cell Lung Cancer (NSCLC)
• Adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. (1.3)
• Adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab. (1.4)
• 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. (1.4)
• 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. (1.4)

Malignant Pleural Mesothelioma
• Adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab. (1.5)

Renal Cell Carcinoma (RCC)
• Adult patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab. (1.6)
• Adult patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib. (1.6)
• Adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. (1.6)

Classical Hodgkin Lymphoma (cHL)
• Adult patients with classical Hodgkin lymphoma that has relapsed or progressed aftera: (1.7)
• 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. (1.8)

Urothelial Carcinoma
• Adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. (1.9)
• Adult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine. (1.9)
• 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. (1.9)

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.a (1.10)

Hepatocellular Carcinoma (HCC)
• Adult patients with hepatocellular carcinoma who have been previously treated with sorafenib in combination with ipilimumab.a (1.11)

Esophageal Cancer
• Adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT). (1.12)
• Adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy. (1.12)
• Adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab. (1.12)
• Adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. (1.12)

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. (1.13)

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Store under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light by storing in the original package until time of use. Do not freeze or shake.