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INDICATED FOR:

Non-Small Cell Lung Cancer

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

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INDICATED FOR:

Non-Small Cell Lung Cancer

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO as adjuvant treatment after surgery.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by OPDIVO Qvantig as monotherapy in the adjuvant setting after surgical resection.

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INDICATED FOR:

Non-Small Cell Lung Cancer

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

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INDICATED FOR:

Non-Small Cell Lung Cancer

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

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INDICATED FOR:

Non-Small Cell Lung Cancer

INTRAVENOUS USE

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with 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.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with 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.

Limitations of Use: OPDIVO Qvantig is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC.

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INDICATED FOR:

Advanced Renal Cell Carcinoma

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC) following treatment with intravenous nivolumab and ipilimumab combination therapy.

Limitations of Use: OPDIVO Qvantig is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma.

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INDICATED FOR:

Advanced Renal Cell Carcinoma

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.

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INDICATED FOR:

Advanced Renal Cell Carcinoma

INTRAVENOUS USE

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy.

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INDICATED FOR:

Gastric, Gastroesophageal Junction, or Esophageal Cancers

INTRAVENOUS USE

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

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INDICATED FOR:

Gastric, Gastroesophageal Junction, or Esophageal Cancers

INTRAVENOUS USE

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.

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INDICATED FOR:

Gastric, Gastroesophageal Junction, or Esophageal Cancers

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

Limitations of Use: OPDIVO Qvantig is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC.

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INDICATED FOR:

Gastric, Gastroesophageal Junction, or Esophageal Cancers

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

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INDICATED FOR:

Gastric, Gastroesophageal Junction, or Esophageal Cancers

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

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INDICATED FOR:

Melanoma

INTRAVENOUS USE

OPDIVO® (nivolumab) is indicated 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.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the adjuvant treatment of adult patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

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INDICATED FOR:

Melanoma

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combination therapy.

Limitations of Use: OPDIVO Qvantig is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma.

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INDICATED FOR:

Melanoma

INTRAVENOUS USE

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic melanoma.

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INDICATED FOR:

Urothelial Carcinoma

INTRAVENOUS USE

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

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INDICATED FOR:

Urothelial Carcinoma

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC.

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INDICATED FOR:

Urothelial Carcinoma

INTRAVENOUS USE

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

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INDICATED FOR:

Malignant Pleural Mesothelioma

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

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INDICATED FOR:

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck on or After Platinum-Based Therapy

INTRAVENOUS USE

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

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INDICATED FOR:

Hepatocellular Carcinoma (HCC) Previously Treated With Sorafenib

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 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 the confirmatory trials.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and following treatment with intravenous nivolumab and ipilimumab.

Limitations of Use: OPDIVO Qvantig is not indicated in combination with ipilimumab for the treatment of patients with HCC.

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 the confirmatory trials.

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INDICATED FOR:

MSI-H/dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment With a Fluoropyrimidine, Oxaliplatin, and Irinotecan

INTRAVENOUS USE

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 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.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy following treatment with intravenous nivolumab and ipilimumab combination therapy, is indicated for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Limitations of Use: OPDIVO Qvantig is not indicated in combination with ipilimumab for the treatment of MSI-H or dMMR metastatic CRC.

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.

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INDICATED FOR:

MSI-H/dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment With a Fluoropyrimidine, Oxaliplatin, and Irinotecan

INTRAVENOUS USE

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 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.

SUBCUTANEOUS USE

OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy), as monotherapy, is indicated for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 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.

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INDICATED FOR:

Relapsed or Progressed cHL After Autologous HSCT and Brentuximab Vedotin or After 3 or More Lines of Therapy Including Autologous HSCT

INTRAVENOUS USE

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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