Table 4.
FDA approval history of checkpoint inhibitors targeting solid tumors.
| Trade Name | Target antigen | Tumor | FDA approval | Indication |
|---|---|---|---|---|
|
| ||||
| Dostarlimab + Ctx | PD-L1 | biliary tract cancer | 2022 | advanced or metastatic biliary tract cancer |
| Pembrolizumab | PD1 | bladder CA | 2020 | second line therapy for invasive bladdar cancer |
| Pembrolizumab | PD1 | Cervical | 2018 | Recurrent or metastatic cervical cancer patients with progression on or after chemotherapy whose tumors express PD-L1 |
| Pembrolizumab + CTx | PD1 | Cervical | 2021 | second line therapy for Cervical cancer with PD-L1 |
| Nivolumab | PD1 | CRC | 2017 | Treatment of patients 12 years and older with dMMR and MSI-H metastatic CRC that has progressed following RX with Fluoropyrimidine, Oxaliplatin, and Irinotecan |
| Nivolumab + Ipilimumab | PD1, CTLA-4 | CRC | 2018 | Metastatic CRC with MSI-H or dMMR |
| Pembrolizumab | PD1 | CRC | 2017 | Unresectable or metastatic, MSI-H CRC |
| Pembrolizumab | PD1 | CRC | 2020 | first line therapy MSI-H or dMMR Colorectal Cancer |
| Dostarlimab | PD-L1 | endometrial cancer | 2021 | second line therapy dMMR endometrial cancer |
| Pembrolizumab + lenvatinib | PD1 | Endometrial carcinoma | 2021 | second line therapy |
| Nivolumab | PD1 | ESCC | 2020 | second line therapy |
| Pembrolizumab | PD1 | ESCC | 2019 | second line therapy |
| Nivolumab | PD1 | Eso or GEJ cancer | 2021 | adjuvant therapy |
| Pembrolizumab + CTx | PD1 | Eso or GEJ carcinoma | 2021 | first line therapy |
| Pembrolizumab | PD1 | Gastric/gastroesophageal junction | 2017 | Recurrent locally advanced or metastatic, gastric or gastroesophageal junction tumors express PD-L1 |
| Pembrolizumab + trastuzumab + CTx | PD1 | GC or GEJ cancer | 2021 | HER2+ first line therapy |
| Nivolumab + CTx | PD1 | GC, GEJ, and Eso adenocarcinoma | 2021 | first line therapy |
| Nivolumab + Ipilimumab | PD1 + CTLA-4 | HCC | 2018 | Intermediate or poor risk advanced hepatocellular carcinoma without prior treatment |
| Pembrolizumab | PD1 | HCC | 2018 | Hepatocellular carcinoma previously treated with Sorafenib |
| Nivolumab | PD1 | HCC | 2017 | Hepatocellular carcinoma previously treated with Sorafenib |
| Nivolumab + ipilimumab | PD1 + CTLA-4 | HCC | 2020 | HCC that has failed sorafenib |
| Atezolizumab + bevacizumab | PD-L1 | HCC | 2020 | first line therapy |
| Dostarlimab +tremelimumab | PD-L1 + CTLA-4 | HCC | 2022 | unresectable HCC |
| Pembrolizumab | PD1 | HNSCC | 2016 | Recurrent or metastatic HNSCC with progression on or after platinum-containing chem |
| Nivolumab | PD1 | HNSCC | 2016 | Advanced HNSCC with progression on/after a platinum-based therapy |
| Pembrolizumab | PD1 | HNSCC | 2020 | HNSCC |
| Pembrolizumab | PD1 | Lymphoma | 2017 | Refractory classical Hodgkin lymphoma patients, or those who have relapsed after three or more prior lines of therapy |
| Nivolumab | PD1 | Lymphoma | 2016 | Recurrent Hodgkin lymphoma following auto HSCT and post-TX Brentuximab Vedotin |
| Pembrolizumab | PD1 | Lymphoma | 2018 | Refractory primary mediastinal large B-cell lymphoma patients, or who have relapsed after two or more prior lines of therapy |
| Nivolumab + ipilimumab | PD1, CTLA-4 | Malignant pleural mesothelioma | 2020 | first line therapy |
| Pembrolizumab | PD1 | Markel cell CA | 2018 | Recurrent locally advanced or metastatic Merkel cell carcinoma |
| Avelumab | PD-L1 | Markel cell CA | 2017 | Metastatic Merkel cell carcinoma |
| Ipilimumab | CTLA-4 | Melanoma | 2015 | Adjuvant treatment of cutaneous melanoma patients with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection |
| Ipilimumab | CTLA-4 | Melanoma | 2011 | Unresectable or metastatic melanoma with previous systematic treatment previously |
| Pembrolizumab | PD1 | Melanoma | 2014 | Unresectable or metastatic melanoma and disease progression following Ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor |
| Pembrolizumab | PD1 | Melanoma | 2015 | Unresectable or metastatic melanoma |
| Nivolumab + Ipilimumab | PD1, CTLA-4 | Melanoma | 2015 | BRAF V600 wild-type, unresectable or metastatic melanoma |
| Nivolumab | PD1 | Melanoma | 2014 | Unresectable or metastatic melanoma and disease progression following Ipilimumab and, if BRAF V600 positive, a BRAF inhibitor |
| Pembrolizumab | PD1 | Melanoma | 2019 | Melanoma with LN involvement following complete resection |
| Nivolumab | PD1 | Melanoma | 2017 | Adjuvant treatment of advanced melanoma |
| relatlimab + Nivolumab | PD1 + LAG-3 | Melanoma | 2022 | Unresectable metastatic melanoma |
| Atezolizumab + CTx | PD-L1 | Melanoma | 2020 | First line therapy BRAF V600E melanoma |
| Atezolizumab | PD-L1 | Non SqCC NSCLC | 2018 | Metastatic disease with no EGFR or ALK genomic tumor mutation |
| Pembrolizumab + CTx | PD1 | Non SqCC NSCLC | 2017 | Previously untreated metastatic non-Sq NSCLC |
| Pembrolizumab CTx | PD1 | Non SqCC NSCLC | 2018 | Metastatic, disease with no EGFR or ALK genomic tumor mutation |
| Atezolizumab + CTx | PD-L1 | Non SqCC NSCLC | 2019 | First line therapy |
| Pembrolizumab | PD1 | NSCLC | 2019 | First-line Rx for stage III NSCLC patients who are not candidates for resection, definitive chemoradiation or metastatic NSCLC. Tumors must have no EGFR or ALK aberrations and be PD-L1+ |
| Atezolizumab | PD-L1 | NSCLC | 2016 | Metastatic NSCLC patients whose disease progressed during or following platinum-containing chemo |
| Nivolumab | PD1 | NSCLC | 2015 | Metastatic NSCLC with progression or after platinum |
| Pembrolizumab | PD1 | NSCLC | 2016 | Metastatic NSCLC patients whose tumors express PD-1 |
| Durvalumab | PD-L1 | NSCLC | 2018 | Unresectable stage III NSCLC whose disease has not progressed following concurrent platinum and radio RX |
| Pembrolizumab | PD1 | NSCLC | 2015 | Unresectable stage III NSCLC whose tumors express PDL1 |
| Atezolizumab + CTx | PD-L1 | NSCLC | 2019 | Metastatic NSCLC patients whose tumors express PD-L1 |
| Nivolumab + ipilimumab | PD1 + CTLA-4 | NSCLC | 2020 | NSCLC expressing PD-L1 >1% |
| Nivolumab + ipilimumab | PD1 + CTLA-4 | NSCLC | 2020 | First line therapy |
| Atezolizumab | PD-L1 | NSCLC | 2020 | NSCLC + high PD-L1 first line therapy |
| Atezolizumab | PD-L1 | NSCLC | 2021 | Adjuvant therapy |
| Dostarlimab + Ctx | PD-L1 | NSCLC | 2022 | Metastatic NSCLC |
| Nivolumab | PD1 | RCC | 2015 | Advanced RCC in patient with prior anti-angiogenic RX |
| Pembrolizumab + CTx | PD1 | RCC | 2019 | First line therapy for RCC |
| Avelumab + CTx | PD-L1 | RCC | 2019 | First line therapy for RCC |
| Nivolumab + cabozantinib | PD1 | RCC | 2021 | first line therapy |
| Pembrolizumab + lenvatinib | PD1 | RCC | 2021 | first line therapy |
| Pembrolizumab | PD1 | RCC | 2021 | adjuvant therapy |
| Cemiplimab-rwlc | PD1 | SCC | 2018 | Metastatic or locally advanced cutaneous squamous cell carcinoma patients who are not candidates for curative surgery or curative radiation |
| Pembrolizumab | PD1 | SCCHN | 2019 | First line therapy for SCCHN |
| Nivolumab | PD1 | SCLC | 2018 | Progressive metastatic small cell lung cancer with progression after platinum |
| Durvalumab + CTx | PD-L1 | SCLC | 2020 | First line therapy |
| Pembrolizumab | PD1 | SCLC | 2019 | third line therapy |
| Dostarlimab | PD-L1 | solid tumors | 2021 | second line therapy dMMR solid tumors |
| Pembrolizumab + CTx | PD1 | Sq NSCLC | 2018 | Metastatic squamous non-small cell lung cancer |
| Nivolumab | PD1 | Sq NSCLC | 2015 | Metastatic squamous NSCLC with progression on or after platinum |
| Atezolizumab | PD-L1 | TNBC | 2019 | Unresectable locally advanced or metastatic TNBC patients whose tumors express PD-L1 |
| Pembrolizumab + CTx | PD1 | TNBC | 2020 | TNBC with PD-L1 |
| Pembrolizumab + CTx | PD1 | TNBC | 2021 | neoadj/adj therapy |
| Nivolumab | PD1 | urothelial | 2017 | Locally advanced or metastatic urothelial carcinoma patients who have disease progression during or after platinum Rx |
| Durvalumab | PD-L1 | urothelial | 2017 | Locally advanced or metastatic urothelial carcinoma patients who have disease progression during or after platinum Rx |
| Atezolizumab | PD-L1 | urothelial | 2016 | Locally advanced or metastatic urothelial carcinoma patients who have disease progression during or after platinum Rx |
| Avelumab | PD-L1 | urothelial | 2017 | Locally advanced or metastatic urothelial carcinoma patients who have disease progression during or after platinum Rx |
| Pembrolizumab | PD1 | urothelial | 2017 | Esophageal/Gastroesophageal Junction Cancer |
| Avelumab | PD-L1 | urothelial | 2020 | first line therapy |
| Nivolumab | PD1 | urothelial carcinoma | 2021 | adjuvant therapy for high-risk urothelial carcinoma |
Neoadj, neoadjuvant; adj, adjuvant; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand-1; LN, lymph nodes; SqCC, squamous cell carcinoma; Non-SqCC, non-squamous cell carcinoma; RCC, renal cell carcinoma; TNBC, triple negative breast cancer; HCC, hepatocellular carcinoma; Eso, Esophageal, GC, gastric cancer; GEJ, gastroesophageal junction, ESCC, esophageal squamous cell carcinoma; CTx, chemotherapy; SCLC, small cell lung cancer; SCCHN, squamous cell carcinoma, head and neck; MSI-H, microsatellite instability high; dMMR, mismatch repair deficient.