FDA approved Yervoy (ipilimumab) for Multiple Indications Including Melanoma and Lung CancerFDA approved Yervoy for several advanced cancers including melanoma and lung cancer.

FDA From the archive Source published March 25, 2011 Summary added June 16, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider Yervoy (ipilimumab) for multiple advanced cancers, often in combination with nivolumab, based on specific indications and patient populations.

The FDA has approved Yervoy (ipilimumab), a CTLA-4-blocking antibody, for a broad range of indications including melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal cancer. For melanoma, Yervoy is approved as a single agent or in combination with nivolumab for unresectable or metastatic disease in adults and pediatric patients 12 years and older, and as adjuvant therapy for adult patients with cutaneous melanoma with lymph node involvement. In renal cell carcinoma, it is indicated as first-line treatment in combination with nivolumab for intermediate or poor risk advanced disease. For colorectal cancer, Yervoy plus nivolumab is approved for MSI-H or dMMR unresectable or metastatic disease. In hepatocellular carcinoma, the combination is indicated for first-line treatment or after sorafenib. For non-small cell lung cancer, Yervoy plus nivolumab is approved for first-line treatment of metastatic PD-L1-positive (≥1%) NSCLC without EGFR or ALK aberrations, and also with chemotherapy for metastatic or recurrent NSCLC. Additionally, Yervoy plus nivolumab is approved for first-line treatment of unresectable malignant pleural mesothelioma and for esophageal squamous cell carcinoma with PD-L1 expression ≥1. These approvals expand treatment options for several advanced cancers.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody. It blocks CTLA-4, enhancing T-cell activation and proliferation, thereby promoting an immune response against tumor cells.

Indication & Patient Population

YERVOY is indicated for: - Unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. - Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. - First-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC) in combination with nivolumab. - Treatment of adults and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with nivolumab. - First-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) in combination with nivolumab, and treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib in combination with nivolumab. - First-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, in combination with nivolumab; and first-line treatment of adult patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy. - First-line treatment of adult patients with unresectable malignant pleural mesothelioma in combination with nivolumab. - First-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) in combination with nivolumab.

Dosing & Administration

Administer by intravenous infusion after dilution based upon recommended infusion rate for each indication. - Unresectable or Metastatic Melanoma: YERVOY 3 mg/kg every 3 weeks for a maximum of 4 doses as a single agent; or YERVOY 3 mg/kg immediately following nivolumab 1 mg/kg on the same day, every 3 weeks for 4 doses, then nivolumab as a single agent. - Adjuvant Treatment of Melanoma: YERVOY 3 mg/kg every 3 weeks for 4 doses, followed by 3 mg/kg every 12 weeks for up to 4 additional doses. - Advanced Renal Cell Carcinoma: YERVOY 1 mg/kg immediately following nivolumab 3 mg/kg on the same day, every 3 weeks for 4 doses, then nivolumab as a single agent. - MSI-H/dMMR Colorectal Cancer: For adult and pediatric patients weighing 40 kg or greater: YERVOY 1 mg/kg immediately following nivolumab 240 mg on the same day every 3 weeks for a maximum of 4 doses, then nivolumab as a single agent.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

YERVOY provides a treatment option for multiple advanced cancers, often in combination with nivolumab, for patients with specific biomarkers or disease characteristics. It is indicated as first-line therapy in several settings and as adjuvant therapy in melanoma.

The FDA has approved Yervoy (ipilimumab) for a wide range of advanced cancers. This includes melanoma, lung cancer, kidney cancer, colon cancer, liver cancer, mesothelioma, and esophageal cancer. Yervoy is a type of immunotherapy that helps the immune system attack cancer cells. It can be used alone or in combination with another drug called nivolumab.

This approval covers many different situations. For example, in melanoma, Yervoy can be used for advanced disease or after surgery. In lung cancer, it is for certain types that have not been treated before. The approval also includes children aged 12 and older with melanoma.

This means more people with advanced cancers now have a new treatment option. However, Yervoy can cause serious side effects, such as inflammation in the lungs, intestines, or skin. It is not a cure, and not everyone will benefit.

If you or a loved one has one of these cancers, talk to your doctor about whether Yervoy might be right for you. Your doctor can explain the risks and benefits based on your specific situation.

What this means for you:

Yervoy is a new immunotherapy option for several advanced cancers; talk to your doctor to see if it fits your treatment plan.

Study Details

Study typeFda approval

PublishedMar 2011

View Original Abstract ↓

1 INDICATIONS AND USAGE YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma • Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. (1.1) • Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. (1.2) Renal Cell Carcinoma (RCC) • Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab. (1.3) Colorectal Cancer • Treatment of adults and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with nivolumab. (1.4) Hepatocellular Carcinoma • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) as first-line treatment in combination with nivolumab. ( 1.5 ) • in combination with nivolumab in adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. (1.5) Non-Small Cell Lung Cancer (NSCLC) • Treatment of 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 nivolumab. (1.6) • Treatment of 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 nivolumab and 2 cycles of platinum-doublet chemotherapy. (1.6) Malignant Pleural Mesothelioma • Treatment of adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with nivolumab. (1.7) Esophageal Cancer • Treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line treatment in combination with nivolumab whose tumors express PD-L1 (≥1). (1.8) 1.1 Unresectable or Metastatic Melanoma YERVOY, as a single agent or in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older. 1.2 Adjuvant Treatment of Melanoma YERVOY is indicated for the adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. 1.3 Advanced Renal Cell Carcinoma YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). 1.4 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer • YERVOY, in combination with nivolumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer ( CRC ). 1.5 Hepatocellular Carcinoma • YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). • YERVOY, in combination with nivolumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. 1.6 Metastatic Non-Small Cell Lung Cancer YERVOY, in combination with nivolumab, 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 [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations. YERVOY, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations. 1.7 Malignant Pleural Mesothelioma YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 1.8 Esophageal Cancer YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .

FDA approved Yervoy (ipilimumab) for Multiple Indications Including Melanoma and Lung CancerFDA approved Yervoy for several advanced cancers including melanoma and lung cancer.

Study Details

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FDA approved Yervoy (ipilimumab) for Multiple Indications Including Melanoma and Lung CancerFDA approved Yervoy for several advanced cancers including melanoma and lung cancer.

Study Details

Experimental agents show response rates up to 70% in relapsed or refractory diffuse large B-cell lymphoma

New cancer therapies double response rates for tough lymphoma

Clinical research that matters. Delivered to your inbox.

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