Table 1.
Approvals for the use of immune checkpoint inhibitors
| Target | Agent | Indication | FDA approval based on registrational trial |
| PD-1 | Pembrolizumab | Colorectal cancer—microsatellite instable | Until progression, unacceptable toxicity, or up to 24 months |
| Cutaneous squamous cell carcinoma | Until progression, unacceptable toxicity, or up to 24 months | ||
| Endometrial carcinoma* | Until progression, unacceptable toxicity, or up to 24 months | ||
| Esophageal carcinoma | Until progression, unacceptable toxicity, or up to 24 months | ||
| Gastric carcinoma | Until progression, unacceptable toxicity, or up to 24 months | ||
| Head and neck squamous cell carcinoma* | Until progression, unacceptable toxicity, or up to 24 months | ||
| Hepatocellular carcinoma | Until progression, unacceptable toxicity, or up to 24 months | ||
| Hodgkin’s lymphoma | Until progression, unacceptable toxicity, or up to 24 months | ||
| Malignant pleural mesothelioma | Until progression, unacceptable toxicity, or up to 24 months | ||
| Melanoma† | Until progression or unacceptable toxicity | ||
| Merkel cell carcinoma | Until progression, unacceptable toxicity, or up to 24 months | ||
| Microsatellite instable cancers (histology agnostic) | Until progression, unacceptable toxicity, or up to 24 months | ||
| Non-small cell lung carcinoma* | Until progression, unacceptable toxicity, or up to 24 months | ||
| Primary mediastinal B-cell lymphoma | Until progression, unacceptable toxicity, or up to 24 months | ||
| Renal cell carcinoma* | Until progression, unacceptable toxicity, or up to 24 months | ||
| Small cell lung carcinoma | Until progression, unacceptable toxicity, or up to 24 months | ||
| Urothelial carcinoma | Until progression, unacceptable toxicity, or up to 24 months | ||
| Nivolumab | Colorectal cancer - microsatellite instable* | Until progression or unacceptable toxicity | |
| Esophageal carcinoma | Until progression or unacceptable toxicity | ||
| Head and neck squamous cell carcinoma* | Until progression or unacceptable toxicity | ||
| Hepatocellular carcinoma* | Until progression or unacceptable toxicity | ||
| Hodgkin’s lymphoma | Until progression or unacceptable toxicity | ||
| Melanoma*† | Until progression or unacceptable toxicity | ||
| Malignant pleural mesothelioma | Until progression, unacceptable toxicity, or up to 24 months | ||
| Non-small cell lung carcinoma* | Until progression or unacceptable toxicity | ||
| Renal cell carcinoma* | Until progression or unacceptable toxicity | ||
| Small cell lung carcinoma* | Until progression or unacceptable toxicity | ||
| Urothelial carcinoma | Until progression or unacceptable toxicity | ||
| Cemiplimab | Cutaneous squamous cell carcinoma | Until progression or unacceptable toxicity | |
| PD-L1 | Atezolizumab | Breast cancer, triple negative* | Until progression or unacceptable toxicity |
| Hepatocellular carcinoma* | Until progression or unacceptable toxicity | ||
| Melanoma* | Until progression or unacceptable toxicity | ||
| Non-small cell lung carcinoma* | Until progression or unacceptable toxicity | ||
| Small cell lung carcinoma* | Until progression or unacceptable toxicity | ||
| Urothelial carcinoma | Until progression or unacceptable toxicity | ||
| Durvalumab | Non-small cell lung carcinoma (Stage III) | Following chemoradiation, until progression, unacceptable toxicity, or up to 12 months | |
| Small cell lung carcinoma* | Until progression or unacceptable toxicity | ||
| Urothelial carcinoma | Until progression or unacceptable toxicity | ||
| Avelumab | Gestational trophoblastic neoplasia | Until progression or unacceptable toxicity, of for three cycles after normalization of hCG | |
| Merkel cell carcinoma | Until progression or unacceptable toxicity | ||
| Renal cell carcinoma* | Until progression or unacceptable toxicity | ||
| Urothelial carcinoma | Until progression or unacceptable toxicity |
*Approval includes combination therapies.
†Approval also exists in the adjuvant setting for 12 months.
FDA, Food and Drug Administration; PD-1, programmed cell death protein 1; PD-L1, programmed death ligand 1.