Table 1.
Immune Checkpoint Inhibitors Approved by FDA by 22nd of July 202120
| Drug | Mechanism | Tumor | Setting | Trial | Approval |
|---|---|---|---|---|---|
| Ipilimumab | CTLA-4 inhibitor | Melanoma | 2nd line | MDX010-020 | 28th of March2011 |
| 1st line (in combination with nivolumab) | CheckMate-069/CheckMate-067 | 1st of October 2015 | |||
| Adjuvant | CA 184-029 | 18th of October 2015 | |||
| RCCa with clear cell histology – intermediate and poor risk groups | 1st line (in combination with nivolumab) | CheckMate-214 | 18th of April 2018 | ||
| MSI- H or dMMR CRCb | 3rd line (in combination with nivolumab) | CheckMate-142 | 10th of July 2018 | ||
| Nivolumab | PD-1 inhibitor | Melanoma | 2nd line | CheckMate-037 | 22nd of December 2014 |
| Adjuvant | CheckMate-238 | 1st of December 2017 | |||
| NSCLCc | 2nd line | CheckMate-017 | 4th of March 2015 | ||
| 2nd line | CheckMate-057 | 1st of October 2015 | |||
| 1st line (in combination with ipilimumab) | CheckMate-227 | 15th of May 2020 | |||
| 1st line (in combination with ipilimumab + chemotherapy) | CheckMate-9LA | 27th of May 2020 | |||
| SCLCd | 3rd line | CheckMate-032 | 17th of August 2018 | ||
| Mesothelioma | 1st line (in combination with ipilimumab) | CheckMate-743 | 2nd of October 2020 | ||
| RCC | 2nd line | CheckMate-025 | 1st of November 2015 | ||
| 1st line (in combination with cabozantinib) | CheckMate-9ER | 22nd of January 2021 | |||
| Hodgkin’s lymphoma | 2nd line | CheckMate-205 | 1st of May 2016 | ||
| HNSCCe | 2nd line | CheckMate-141 | 1st of November 2016 | ||
| MSI- H or dMMR CRC | 2nd line | CheckMate-142 | 1st of August 2017 | ||
| 3rd line (in combination with ipilimumab) | CheckMate-142 | 10th of July 2018 | |||
| HCCf | 2nd line | CheckMate-040 | 1st of September 2017* | ||
| 2nd line (in combination with ipilimumab) | CheckMate-040 | 11th of March 2020 | |||
| Bladder cancer | 2nd line | CheckMate-275 | 1st of February 2017 | ||
| Esophagus cancer | 2nd line | ATTRACTION-3 | 11th of June 2020 | ||
| 1st line (in combination with chemotherapy) | CheckMate-649 | 16th of April 2021 | |||
| Adjuvant (in combination with chemoradiotherapy) | CheckMate-577 | 20th of May 2021 | |||
| Gastric cancer | 1st line (in combination with chemotherapy) | CheckMate-649 | 16th of April 2021 | ||
| Pembrolizumab | PD-1 inhibitor | Melanoma | 2nd line | KEYNOTE-001 | 1st of September 2014 |
| 2nd line | KEYNOTE-002 | 1st of December 2015 | |||
| 1st line | KEYNOTE-006 | 1st of December 2015 | |||
| Adjuvant | EORTC 1325/KEYNOTE-054 | 15th of February 2019 | |||
| NSCLC | 2nd line | KEYNOTE-001; KEYNOTE-006 | 1st of October 2015 | ||
| 1st line | KEYNOTE-024 | 1st of October 2016 | |||
| 1st line (in combination with chemotherapy) | KEYNOTE-021 | 1st of May 2017 | |||
| 1st line (in combination with chemotherapy) | KEYNOTE-189 | 20th of August 2018 | |||
| 1st line (in combination with chemotherapy) | KEYNOTE-407 | 31st of October 2018 | |||
| 1st line | KEYNOTE-042 | 11th of April 2019 | |||
| SCLC | 3rd line | KEYNOTE-158; KEYNOTE-028 | 18th of June 2019** | ||
| RCC | 1st line (in combination with TKI) | KEYNOTE-426 | 19th of April 2019 | ||
| HNSCC | 2nd line | KEYNOTE-012 | 1st of August 2016 | ||
| 1st line (alone or in combination with chemotherapy) | KEYNOTE-048 | 10th of June 2019 | |||
| Hodgkin’s lymphoma | 2nd line | KEYNOTE-087 | 1st of March 2017 | ||
| 2nd line | KEYNOTE-204 | 15th of October 2020 | |||
| PMBCLg | 3rd line | KEYNOTE-170 | 13th of June 2018 | ||
| Merkel cell carcinoma | 1st line | CITN-09/KEYNOTE-017 | 19th of December 2018 | ||
| Cutaneous squamous cell carcinoma | 1st line | KEYNOTE-629 | 24th of June 2020 | ||
| MSI-H or dMMR tumors | 2nd line | NCT01876511 | 1st of May 2017 | ||
| TMB-H tumors | 2nd line | KEYNOTE-158 | 16th of June 2020 | ||
| Esophagus cancer | 2nd line | KEYNOTE-180; KEYNOTE-181 | 31st of July 2019 | ||
| 1st line (in combination with chemotherapy) | KEYNOTE-590 | 22nd of March 2021 | |||
| CCR | 1st line | KEYNOTE-177 | 29th of June 2020 | ||
| Gastric cancer | 3rd line | KEYNOTE-059 | 1st of September 2017* | ||
| 1st line (in combination with Trastuzumab and chemotherapy) | KEYNOTE-811 | 5th of May 2021 | |||
| Hepatocellular carcinoma | 2nd line | KEYNOTE-240 | 9th of November 2018 | ||
| Cervical cancer | 2nd line | KEYNOTE-158 | 12th of June 2018 | ||
| Bladder cancer | 2nd line | KEYNOTE-045 | 1st of May 2017 | ||
| 1st line | KEYNOTE-052 | 1st of May 2017 | |||
| 2nd line | KEYNOTE-057 | 8th of January 2020 | |||
| TNBCh | 1st line (in combination with chemotherapy) | KEYNOTE-355 | 13th of November 2020 | ||
| Endometrial carcinoma | 2nd line (in combination with lenvatinib) | KEYNOTE-775/Study 309 | 22nd of July 2021 | ||
| Cemiplimab | PD-1 inhibitor | Cutaneous squamous cell carcinoma | 1st line | NCT02760498 | 28th of September 2018 |
| Basal cell carcinoma | 2nd line | NCT03132636 | 9th of February 2021 | ||
| NSCLC | 1st line | EMPOWER-Lung1 | 22nd of February 2021 | ||
| Dostarlimab | PD-1 inhibitor | Endometrial carcinoma | 2nd line | GARNET | 22nd of April 2021 |
| Avelumab | PD-L1 inhibitor | Merkel cell carcinoma | 2nd line | JAVELIN Merkel 200 | 1st of March 2017 |
| Bladder cancer | 2nd line | JAVELIN Solid Tumor | 1st of May 2017 | ||
| 1st line | JAVELIN Bladder 100 | 30th of June 2020 | |||
| RCC | 1st line (in combination with Axitinib) | JAVELIN Renal 101 | 15th of May 2019 | ||
| Atezolizumab | PD-L1 inhibitor | Bladder cancer | 2nd line | IMvigor210 | 1st of May 2016** |
| 1st line | IMvigor210 | 1st of April 2017** | |||
| NSCLC | 2nd line | Birch, Poplar, FIR, Oak | 1st of October 2016 | ||
| 1st line (in combination with bevacizumab, carboplatin and paclitaxel) | IMpower150 | 6th of December 2018 | |||
| 1st line (in combination with carboplatin/nab-paclitaxel) | IMpower130 | 3rd of December 2019 | |||
| 1st line | IMpower110 | 18th of May 2020 | |||
| SCLC | 1st line (in combination with carboplatin and etoposide) | IMpower133 | 19th of March 2019 | ||
| Melanoma | 1st line (in combination with cobimetinib and vemurafenib) | IMspire150 | 30th of July 2020 | ||
| HCC | 1st line (in combination with bevacizumab) | IMbrave150 | 29th of May 2020 | ||
| TNBC | 1st line (in combination with nab-paclitaxexl) | IMpassion130 | 8th of March 2019 | ||
| Durvalumab | PD-L1 inhibitor | Bladder cancer | 2nd line | NCT01693562 | 1st of May 2017** |
| NSCLC | Adjuvant | PACIFIC | 16th of February 2018 | ||
| SCLC | 1st line (in combination with etoposide and carbo/cisplatin) | CASPIAN | 30th of March 2020 |
Notes: aRenal cell carcinoma. bColorectal cancer. cNon-small cell lung cancer. dSmall cell lung cancer. eHead and neck squamous cell carcinoma. fHepatocellular carcinoma. gPrimary mediastinal B-cell lymphoma. hTriple-negative breast cancer. *As per April 2021, the FDA voted against maintaining accelerated approval. **Withdrawn due to failure to meet post-marketing requirements. Adapted with permission from FDA approval timeline of active immunotherapies; 2021. Available from: https://www.cancerresearch.org/en-us/scientists/immuno-oncology-landscape/fda-approval-timeline-of-activeimmunotherapies.20