Skip to main content
. 2020 Nov 17;12(11):3401. doi: 10.3390/cancers12113401

Table 1.

Approved ICIs by FDA and EMA.

ICI Molecular Target FDA-Approved Indication
(Year of Approval) a 		EMA-Approved Indication
(Year of Approval) a
Ipilimumab CTLA-4 Melanoma:
  • –

    adults, metastatic (2011);

  • –

    BRAF V600 wild-type unresectable/metastatic, in combination with nivolumab (2015);

  • –

    adjuvant treatment, stage III (2015);

  • –

    unresectable/metastatic regardless of BRAF mutational status, in combination with nivolumab (2016);

  • –

    pediatric patients ≥12 years, unresectable/metastatic (2017).

 Melanoma:
  • –

    adults, unresectable or metastatic (2011);

  • –

    pediatric patients ≥12 years, unresectable/metastatic (2018);

  • –

    advanced, in combination with nivolumab (2016).

Renal cell carcinoma:
  • –

    first-line, intermediate/poor-risk, advanced, in combination with nivolumab (2018).

 Renal cell carcinoma:
  • –

    first-line, intermediate/poor-risk, advanced, in combination with nivolumab (2018).
Colorectal cancer:
  • –

    microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), metastatic, previously treated with a fluoropyrimidine, oxaliplatin and irinotecan, in combination with nivolumab (2018).
Hepatocellular carcinoma:
  • –

    previously treated with sorafenib, in combination with nivolumab (2020).
Non-small cell lung cancer (NSCLC) (squamous and non-squamous):
  • –

    first-line, metastatic, ≥1% PD-L1, without EGFR or ALK mutations, in combination with nivolumab (2020);

  • –

    first-line, metastatic or recurrent, without EGFR or ALK mutations, in combination with nivolumab and two cycles of platinum-doublet chemotherapy (2020).

 NSCLC (squamous and non-squamous):
  • –

    first-line, metastatic, without EGFR or ALK mutations, in combination with nivolumab and two cycles of platinum-doublet chemotherapy (2020).
Mesothelioma:
  • –

    previously untreated unresectable, in combination with nivolumab (2020).
Nivolumab PD-1 Melanoma:
  • –

    unresectable/metastatic and resistant to other agents (2014);

  • –

    unresectable/metastatic, BRAF V600 wild-type, in combination with ipilimumab (2015);

  • –

    unresectable/metastatic, regardless of BRAF mutational status, in combination with ipilimumab (2016);

  • –

    adjuvant, lymph node involvement or metastatic, after completely resection of the tumor (2017).

 Melanoma:
  • –

    unresectable or metastatic, regardless of BRAF mutational status, as single agent (2015) or in combination with ipilimumab (2016);

  • –

    adjuvant, lymph node involvement or metastatic, after completely resection of the tumor (2018).

NSCLC (squamous or non-squamous):
  • –

    metastatic, in progression during or after platinum-based chemotherapy (2015);

  • –

    first-line, metastatic, ≥1% PD-L1, without EGFR or ALK mutations, in combination with ipilimumab (2020);

  • –

    first-line, metastatic or recurrent, without EGFR or ALK mutations, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy (2020).

 NSCLC:
  • –

    locally advanced or metastatic forms, following prior chemotherapy (2016);

  • –

    first-line, metastatic or recurrent, without EGFR or ALK mutations, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy (2020).
Small cell lung cancer (SCLC):
  • –

    metastatic, progressed after platinum-based chemotherapy and at least one other line of therapy (2018).
Mesothelioma:
  • –

    first-line, unresectable, in combination with ipilimumab (2020).
Renal cell carcinoma:
  • –

    advanced/metastatic, previously treated with antiangiogenic therapy (2015);

  • –

    first-line, advanced, intermediate/poor-risk, in combination with ipilimumab (2018).

 Renal cell carcinoma:
  • –

    advanced, after prior therapy (2016);

  • –

    first-line, advanced, intermediate/poor-risk, in combination with ipilimumab (2018).
Classical Hodgkin lymphoma:
  • –

    relapsed/progressed after autologous hematopoietic stem cell transplantation and brentuximab vedotin and/or ≥3 lines of prior systemic therapy (2016).

 Classical Hodgkin lymphoma:
  • –

    relapsed/progressed after autologous hematopoietic stem cell transplantation and brentuximab vedotin (2016).

Head and neck squamous cell carcinoma:
  • –

    recurrent or metastatic with disease progression during or after platinum-based chemotherapy (2016).

 Head and neck squamous cell carcinoma:
  • –

    recurrent or metastatic, with disease progression during or after platinum-based chemotherapy (2017).
Urothelial carcinoma:
  • –

    locally advanced or metastatic, in progression during or after platinum-containing chemotherapy or within 12 months from platinum-containing adjuvant or neoadjuvant chemotherapy (2017).

 Urothelial carcinoma:
  • –

    locally advanced, unresectable or metastatic, as second-line treatment, after failure of prior platinum-based chemotherapy (2017).
Colorectal cancer:
  • –

    adult and pediatric patients, metastatic with MSI-H or dMMR metastatic, progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent (2017) or in combination with ipilimumab (2018).
Hepatocellular carcinoma:
  • –

    previously treated with sorafenib, as single agent (2017) or in combination with ipilimumab (2020).
Esophageal squamous cell carcinoma:
  • –

    unresectable, advanced, recurrent or metastatic, after prior fluoropyrimidine and platinum-based chemotherapy (2020).

    combination with ipilimumab (2018).

 Esophageal squamous cell carcinoma:
  • –

    unresectable advanced, recurrent or metastatic, after prior fluoropyrimidine- and platinum-based chemotherapy (2020).

Pembrolizumab PD-1 Melanoma:
  • –

    unresectable or metastatic non-responding to previous treatment (2014) and as first-line regardless of BRAF mutational status (2015);

  • –

    adjuvant, completely resected, with lymph node involvement (2019).

 Melanoma:
  • –

    first-line, unresectable or metastatic (2015);

  • –

    adjuvant, completely resected, with lymph node involvement (2018).
NSCLC:
  • –

    advanced/metastatic, progressed after other treatments and expressing PD-L1 (2015);

  • –

    first-line, metastatic, high (≥50%) PD-L1 (2016);

  • –

    first-line, metastatic, non-squamous, in combination with pemetrexed and carboplatin (2017) and without EGFR or ALK mutations (2018), irrespective of PD-L1 expression;

  • –

    first-line, metastatic, squamous, in combination with carboplatin and either paclitaxel or nab-paclitaxel (2018);

  • –

    first-line, metastatic or stage III not candidate for surgical resection or definitive chemo-radiotherapy, ≥1% PD-L1 (2019).

 NSCLC:
  • –

    locally advanced or metastatic, after at least one prior chemotherapy regimen, high (≥50%) PD-L1 (2016);

  • –

    first-line, metastatic, with high PD-L1 expression, without EGFR or ALK mutations (2017);

  • –

    first-line, metastatic non-squamous, without EGFR or ALK mutations in combination with pemetrexed and a platinum compound (2017);

  • –

    first-line, metastatic, squamous, in combination with carboplatin and either paclitaxel or nab-paclitaxel (2019).
SCLC:
  • –

    metastatic, progressing on or after platinum-based chemotherapy (2019).
Head and neck squamous cellcarcinoma:
  • –

    recurrent or metastatic, progressing on or after platinum-based chemotherapy (2016);

  • –

    first-line, metastatic or unresectable, recurrent, as monotherapy in tumors expressing ≥1% PD-L1 or in combination with platinum and 5-fluorouracil (2019).

 Head and neck squamous cellcarcinoma:
  • –

    recurrent or metastatic, progressing on or after platinum-based chemotherapy, with high PD-L1 (2018);

  • –

    metastatic or unresectable, recurrent, as monotherapy in tumors expressing ≥1% PD-L1 or with platinum and 5-fluorouracil (2019).
Classical Hodgkin lymphoma:
  • –

    adult and pediatric patients, refractory or relapsed after ≥3 prior lines (2017) or ≥2 prior lines of therapy (2020).

 Classical Hodgkin lymphoma:
  • –

    refractory or relapsed after autologous hematopoietic stem cell transplantation and brentuximab vedotin or who are transplant-ineligible and have failed brentuximab vedotin (2017).
Urothelial carcinoma:
  • –

    locally advanced or metastatic, not eligible for cisplatin-containing chemotherapy (as first-line, 2017), ≥10% PD-L1 (2018) or progressing during or following platinum-containing chemotherapy (2017);

  • –

    high-risk, non-muscle invasive bladder cancer, with carcinoma in situ, with or without papillary tumors, not eligible for cystectomy and unresponsive to Bacillus Calmette-Guérin (BCG) (2020).

 Urothelial carcinoma:
  • –

    locally advanced or metastatic, not eligible for cisplatin-containing chemotherapy (2017), ≥10% PD-L1 (2018) or after platinum-containing chemotherapy (2017).
Renal cell carcinoma:
  • –

    first-line, advanced, in combination with axitinib (2019).

 Renal cell carcinoma:
  • –

    first-line, advanced, in combination with axitinib (2019).
Gastric or gastroesophageal junction cancer:
  • –

    recurrent, locally advanced or metastatic, ≥1% PD-L1, progressing on or after ≥2 prior lines of therapy with a fluoropyrimidine, platinum-containing and anti-HER2 therapy (2017).
Cervical cancer:
  • –

    recurrent or metastatic, ≥1% PD-L1, progressing on or after chemotherapy (2018).
Primary mediastinal large B-cell lymphoma:
  • –

    adult and pediatric patients, refractory or relapsed after ≥2 lines of therapy (2018).
Hepatocellular carcinoma:
  • –

    previously treated with sorafenib (2018).
Merkel cell carcinoma:
  • –

    adult and pediatric patients, recurrent, locally advanced or metastatic (2018).
Esophageal squamous cell carcinoma:
  • –

    recurrent locally advanced or metastatic, ≥10% PD-L1, progressing after ≥1 line of therapy (2019).
Endometrial carcinoma:
  • –

    advanced, not MSI-H or dMMR, not candidate for curative surgery or radiotherapy, in combination with lenvatinib (2019).
Cutaneous squamous cell carcinoma:
  • –

    recurrent or metastatic, not curable by surgery or radiotherapy (2020).
Colorectal cancer:
  • –

    unresectable or metastatic, progressing after treatment with a fluoropyrimidine, oxaliplatin and irinotecan (2017);

  • –

    first-line, unresectable or metastatic, MSI-H or dMMR (2020).
Solid tumors:
  • –

    adult and pediatric patients, unresectable or metastatic, MSI-H or dMMR (2017) or high tumor mutational burden (2020) progressing after prior treatment and without satisfactory alternative therapeutic options.
Cemiplimab PD-1 Cutaneous squamous cell carcinoma:
  • –

    metastatic or locally advanced not eligible for curative surgery or radiotherapy (2018).

 Cutaneous squamous cell carcinoma:
  • –

    metastatic or locally advanced not eligible for curative surgery or radiotherapy (2019).
Atezolizumab PD-L1 Urothelial carcinoma:
  • –

    locally advanced or metastatic, worsened during or following platinum-containing chemotherapy or within 12 months from platinum-containing adjuvant or neoadjuvant chemotherapy (2016);

  • –

    locally advanced or metastatic, not eligible for any platinum-containing chemotherapy regardless of PD-L1 expression level (2017) or not eligible for cisplatin-containing chemotherapy, ≥5% PD-L1 (2018).

 Urothelial carcinoma:
  • –

    locally advanced or metastatic, after prior platinum-containing chemotherapy, or

  • cisplatin-ineligible (2017) and ≥10% PD-L1 (2018).
NSCLC:
  • –

    metastatic, progressing during or after platinum-containing chemotherapy or, in case of tumors with EGFR or ALK mutation, after prior targeted agents (2016);

  • –

    first-line, metastatic, non-squamous, without EGFR or ALK mutations, in combination with bevacizumab, paclitaxel and carboplatin (2018);

  • –

    first-line, metastatic, non-squamous, without EGFR or ALK mutations, in combination with nab-paclitaxel and carboplatin (2019);

  • –

    first-line, metastatic, high PD-L1 (i.e., 50% of tumor cells or PD-L1 positive tumor-infiltrating immune cells covering ≥ 10% of the tumor area) (2020).

 NSCLC:
  • –

    locally advanced or metastatic, non-squamous, after prior chemotherapy or, in case of tumors with EGFR or ALK mutation, after prior targeted agents (2017);

  • –

    first-line, metastatic, non-squamous, without EGFR or ALK mutations, in combination with bevacizumab, paclitaxel and carboplatin; if EGFR or ALK mutation are present, the combination with bevacizumab, paclitaxel and carboplatin is administered only after failure of targeted agents (2019);

  • –

    first-line, metastatic, non-squamous, without EGFR or ALK mutations, in combination with nab-paclitaxel and carboplatin (2019).
SCLC:
  • –

    first-line, extensive-stage, in combination with carboplatin and etoposide (2019).

 SCLC:
  • –

    first-line, extensive-stage, in combination with carboplatin and etoposide (2019).
Triple-negative breast cancer:
  • –

    unresectable locally advanced or metastatic, ≥1% PD-L1, in combination with nab-placlitaxel (2019).

 Triple-negative breast cancer:
  • –

    unresectable locally advanced or metastatic, ≥1% PD-L1, not receiving prior chemotherapy (2019).
Hepatocellular carcinoma:
  • –

    unresectable or metastatic disease, not receiving prior systemic therapy, in combination with bevacizumab (2020).

 Hepatocellular carcinoma:
  • –

    advanced or unresectable carcinoma, not receiving prior systemic therapy, in combination with bevacizumab (2020).
Melanoma:
  • –

    BRAF V600 mutation-positive, advanced, in combination with vemurafenib and cobimetinib (2020).
Durvalumab PD-L1 Urothelial carcinoma:
  • –

    locally advanced or metastatic, progressing during or following platinum-containing chemotherapy or within 12 months from platinum-containing adjuvant or neoadjuvant chemotherapy (2017).
NSCLC:
  • –

    unresectable stage III, not progressed after platinum-based chemotherapy and radiotherapy (2018).

 NSCLC:
  • –

    locally advanced, unresectable tumor, ≥1% PD-L1, not progressed after platinum-based chemotherapy and radiotherapy (2018).
SCLC:
  • –

    first-line, extensive-stage, in combination with platinum-etoposide (2020).

 SCLC:
  • –

    first-line, extensive-stage, in combination with platinum-etoposide (2020).
Avelumab PD-L1 Merkel cell carcinoma:
  • –

    adult and pediatric patients, metastatic, not receiving prior chemotherapy (2017).

 Merkel cell carcinoma:
  • –

    metastatic (2017).
Urothelial carcinoma:
  • –

    locally advanced or metastatic disease, progressing during or following platinum-containing chemotherapy or within 12 months from platinum-containing adjuvant or neoadjuvant

chemotherapy (2017);
  • –

    first-line maintenance treatment, locally advanced or metastatic, not progressed following first-line platinum-based chemotherapy (2020).
Renal cell carcinoma:
  • –

    first-line, advanced, in combination with axitinib (2019).

 Renal cell carcinoma:
  • –

    first-line, advanced, in combination with axitinib (2019).

a Data updated to October 2020.