Table 1. Summary of immune checkpoint blockade therapies which have been approved by the FDA for being applied in clinical practices. https://www.fda.gov/.
| Antibody | Immunotherapy | Trading name | Cancer type | Indications | Date of approval |
|---|---|---|---|---|---|
| anti–PD-L1 | Durvalumab |
O IMFINZI, AstraZeneca + etoposide and either carboplatin or cisplatin |
Extensive-stage small cell lung cancer (ES-SCLC) | First-line treatment | March 30, 2020 |
| O IMFINZI, AstraZeneca Inc. | Unresectable stage III non-small cell lung cancer (NSCLC) |
Disease should not be progressed following concurrent platinum-based chemotherapy and radiation therapy | February 16, 2018 | ||
| O IMFINZI, AstraZeneca UK Limited) | locally advanced or metastatic urothelial carcinoma |
disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy | May 1, 2017 | ||
| Avelumab |
O BAVENCIO, EMD Serono Inc. + axitinib |
Advanced renal cell carcinoma (RCC) | First-line treatment | May 14, 2019 | |
| O BAVENCIO, EMD Serono, Inc. | Locally advanced or metastatic urothelial carcinoma | Progressed disease during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy | May 9, 2017 | ||
| O BAVENCIO, EMD Serono, Inc. | Metastatic Merkel cell carcinoma (MCC). | The first FDA-approved product to treat this type of cancer. For 12 years and older |
March 23, 2017 | ||
| Atezolizumab | O TECENTRIQ®, Genentech Inc. | Metastatic non-small cell lung cancer (NSCLC) | first-line treatment adults with high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells [TC ≥ 50%] or PD-L1 stained tumour-infiltrating immune cells [IC] covering ≥ 10% of the tumour area [IC ≥ 10%]), with no EGFR or ALK genomic tumour aberrations. |
May 18, 2020 | |
|
O TECENTRIQ, Genentech Inc. + paclitaxel protein-bound and carboplatin |
Metastatic non-squamous non-small cell lung cancer (NSCLC) | First-line treatment for adults (with no EGFR or ALK genomic tumour aberrations) |
December 3, 2019 | ||
|
O TECENTRIQ, Genentech Inc. + carboplatin and etoposide |
Extensive-stage small cell lung cancer (ES-SCLC) | First-line treatment for adults | March 18, 2019 | ||
|
O TECENTRIQ, Genentech Inc. + paclitaxel protein-bound |
Unresectable locally advanced or metastatic triple-negative breast cancer | PD-L1 (SP142) positive | March 8, 2019 | ||
| O TECENTRIQ, Genentech, Inc. + bevacizumab, paclitaxel, and carboplatin |
Metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) | First-line treatment of patients with no EGFR or ALK genomic tumour aberrations. | December 6, 2018 | ||
| O TECENTRIQ, Genentech Inc. | Locally advanced or metastatic urothelial carcinoma | Not eligible for cisplatin-containing chemotherapy, and whose tumours express PD-L1 (PD-L1 stained tumour-infiltrating immune cells [IC] covering ≥5% of the tumour area) Or Not eligible for any platinum-containing therapy regardless of level of tumour PD-L1 expression |
August 16, 2018. | ||
| O TECENTRIQ, Genentech Oncology | Metastatic non-small cell lung cancer (NSCLC) | Progressed disease during or following platinum-containing chemotherapy EGFR or ALK genomic tumour aberrations with disease progression |
October 18, 2016 | ||
| O TECENTRIQ, Genentech Inc. | Locally advanced or metastatic urothelial carcinoma | Disease progression during or following platinum-containing chemotherapy or Progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy |
May 18, 2016 | ||
| anti–PD-1 |
Nivolumab | O OPDIVO, Bristol-Myers Squibb Company. | Metastatic small cell lung cancer (SCLC) | Progression after platinum-based chemotherapy and at least one other line of therapy | August 16, 2018 |
| O OPDIVO, Bristol-Myers Squibb Company | Melanoma | Adjuvant treatment with involvement of lymph nodes or with metastatic disease who have undergone complete resection. |
December 20, 2017 | ||
| O OPDIVO, Bristol-Myers Squibb Co. | Hepatocellular carcinoma (HCC) | Previously treated with sorafenib. | September 22, 2017 | ||
| O OPDIVO, Bristol-Myers Squibb Co. | Metastatic colorectal cancer | -12 years and older -Mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) -Malignancy progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan |
August 1, 2017 | ||
| O OPDIVO, Bristol-Myers Squibb Co. | Locally advanced or metastatic urothelial carcinoma | Progression during or following platinum-containing chemotherapy or Have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy |
February 2, 2017 | ||
| O OPDIVO, Bristol-Myers Squibb Co. | Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) | Progression on or after a platinum-based therapy | November 10, 2016 | ||
| O OPDIVO, Bristol-Myers Squibb Co | Advanced renal cell carcinoma | Patients who have received prior anti-angiogenic therapy | November 23, 2015 | ||
| O OPDIVO, Bristol-Myers Squibb Co | Metastatic non-small cell lung cancer (NSCLC) | Progression on or after platinum-based chemotherapy. EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for these aberrations prior to therapy |
October 9, 2015 | ||
| O OPDIVO, Bristol-Myers Squibb Co | Unresectable or metastatic melanoma | Progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor | December 22, 2014 | ||
| pembrolizumab | O KEYTRUDA, Merck & Co. Inc | New dosing regimen | 400 mg every 6 weeks for pembrolizumab across all currently approved adult indications, in addition to the current 200 mg every three weeks dosing regimen. | April 28, 2020 | |
| O KEYTRUDA, Merck & Co. Inc. | Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) | With carcinoma in situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy. | January 8, 2020 | ||
|
O KEYTRUDA, Merck + lenvatinib (LENVIMA, Eisai) |
Advanced endometrial carcinoma | That is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) Have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. |
September 17, 2019 | ||
| O KEYTRUDA, Merck & Co. Inc. | Advanced esophageal squamous cell cancer | Tumour PD-L1 expression (Combined Positive Score [CPS] ≥10), determined by an FDA-approved test Disease progression after one or more prior lines of systemic therapy. |
July 30, 2019 | ||
| O KEYTRUDA, Merck & Co. Inc. | Metastatic small cell lung cancer (SCLC) | Disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. | June 17, 2019 | ||
| O KEYTRUDA, Merck & Co. Inc. | Metastatic small cell lung cancer (SCLC) | Disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. | June 17,2019 | ||
| O KEYTRUDA, Merck & Co. Inc. | Metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) | First-line treatment |
June 10, 2019 | ||
|
O KEYTRUDA, Merck & Co. Inc. + axitinib |
Advanced renal cell carcinoma (RCC) | First-line treatment |
April 19, 2019 | ||
| O KEYTRUDA, Merck & Co. Inc. | Stage III non-small cell lung cancer (NSCLC) | First-line treatment -Not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. -Patients’ tumours must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumour Proportion Score [TPS] ≥1%) determined by an FDA-approved test. |
April 11, 2019 | ||
| O KEYTRUDA, Merck & Co. Inc. | Melanoma | Adjuvant treatment -With involvement of lymph node(s) following complete resection. |
February 15, 2019 | ||
| O KEYTRUDA, Merck & Co. Inc. | Recurrent locally advanced or metastatic Merkel cell carcinoma (MCC) | Adult and pediatric patients | December 19, 2018 | ||
| O KEYTRUDA, Merck & Co. Inc. | Hepatocellular carcinoma (HCC) | Previously treated with sorafenib | November 9, 2018 | ||
|
O KEYTRUDA, Merck & Co. Inc. + carboplatin and either paclitaxel or nab-paclitaxel |
Metastatic squamous non-small cell lung cancer (NSCLC) | First-line treatment | October 30, 2018 | ||
|
O KEYTRUDA, Merck & Co. Inc. + Pemetrexed,platinum |
Metastatic, non-squamous non-small cell lung cancer (NSqNSCLC) | First-line treatment with no EGFR or ALK genomic tumour aberrations |
August 20, 2018 | ||
| O KEYTRUDA, Merck & Co. Inc | Locally advanced or metastatic urothelial cancer |
PD-L1 levels evaluation in tumour tissue who are cisplatin-ineligible. PD-L1 expression CPS ≥ 10 as determined by an FDA-approved test Or not eligible for any platinum-containing chemotherapy regardless of PD-L1 status |
August 16, 2018 | ||
| O KEYTRUDA, Merck & Co. Inc | Refractory primary mediastinal large B-cell lymphoma (PMBCL) | Treatment of adult and pediatric patients, relapsed after two or more prior lines of therapy. |
June 13, 2018 | ||
| O KEYTRUDA, Merck & Co. Inc | Recurrent or metastatic cervical cancer | Disease progression on or after chemotherapy PD-L1 expression (CPS ≥1) as determined by an FDA-approved test |
June 12, 2018 | ||
| O KEYTRUDA, Merck & Co. Inc | Recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma | PD-L1 expression as determined by an FDA-approved test Disease progression on or after two or more prior systemic fluoropyrimidine- and platinum-containing chemotherapy and, HER2/neu-targeted therapy |
September 22, 2017 |
||
| O KEYTRUDA, Merck & Co. Inc | Unresectable or metastatic colorectal cancer | Adult and pediatric patients unresectable or metastatic, MSI-H or dMMR solid tumours progressed following prior treatment with no satisfactory alternative treatment options or MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. |
May 23, 2017 | ||
| O KEYTRUDA, Merck & Co. Inc | Locally advanced or metastatic urothelial carcinoma | Disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. | May 18, 2017 | ||
|
O KEYTRUDA, Merck & Co. Inc + pemetrexed and carboplatin |
Metastatic non-squamous non-small cell lung cancer (NSCLC) | Previously untreated | May 10, 2017 | ||
| O KEYTRUDA, Merck & Co. Inc | Metastatic non-small cell lung cancer (NSCLC) | Tumours express PD-L1 as determined by an FDA-approved test | October 24, 2016 | ||
| O KEYTRUDA, Merck & Co. Inc | Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) | Disease progression on or after platinum-containing chemotherapy | August 5, 2016 | ||
| O KEYTRUDA, Merck & Co. Inc | Unresectable or metastatic melanoma | . | December 18, 2015 | ||
| O KEYTRUDA, Merck & Co. Inc | Metastatic non-small cell lung cancer (NSCLC) | Tumours express PD-L1 as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy | October 2, 2015 | ||
| O KEYTRUDA, Merck & Co. Inc | Unresectable or metastatic melanoma | Disease progression following ipilimumab BRAF V600 mutation positive |
September 4, 2014 | ||
| anti-CTLA4 | Ipilimumab | O YERVOY, Bristol-Myers Squibb Company | Cutaneous melanoma | Additional indication of adjuvant treatment of patients Pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy |
October 28, 2015 |
| O YERVOY, Bristol-Myers Squibb Company | Unresectable or metastatic melanoma | March 25, 2011 | |||
| Nivolumab + ipilimumab |
O nivolumab (OPDIVO, Bristol-Myers Squibb Co.) + ipilimumab (YERVOY, Bristol-Myers Squibb Co.) + 2 cycles of platinum-doublet chemotherapy |
Metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal | As first-line treatment With growth factor receptor (EGFR) or anaplastic lymphoma kinase(ALK) genomic tumour aberrations. |
May 26, 2020 | |
| Combination therapy | O nivolumab (OPDIVO, Bristol-Myers Squibb Co.) + ipilimumab (YERVOY, Bristol-Myers Squibb Co.) |
Metastatic non-small cell lung cancer | As first-line treatment Tumours express PD-L1(≥1%), as determined by an FDA-approved test With no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations |
May 15, 2020 | |
| O nivolumab (OPDIVO, Bristol-Myers Squibb Co.) + ipilimumab (YERVOY, Bristol-Myers Squibb Co.) |
Hepatocellular carcinoma (HCC) | Previously treated with sorafenib.. | March 10, 2020 | ||
|
O nivolumab (OPDIVO, Bristol-Myers Squibb Co.) + ipilimumab (YERVOY, Bristol-Myers Squibb Co.) |
Advanced renal cell carcinoma | Intermediate or poor risk previously untreated |
April 16, 2018 | ||
|
O nivolumab (OPDIVO, Bristol-Myers Squibb Co.) + ipilimumab (YERVOY, Bristol-Myers Squibb Co.) |
Unresectable or metastatic melanoma | With BRAF V600 wild-type | September 30, 2015 |
O approved
O accelerated approva
O updated prescribing information
ALK: anaplastic lymphoma kinase; EGFR: epidermal growth factor receptor; HER2: human epidermal growth factor receptor 2