| Afatinib | US FDA | — | Efficacy supplement 2022-04-07 (see label) | approved | Apr 7, 2022 | openfda |
| Afatinib | US FDA | — | Efficacy supplement 2018-01-12 (see label) | approved | Jan 12, 2018 | openfda |
| Afatinib | US FDA | — | Efficacy supplement 2016-04-15 (see label) | approved | Apr 15, 2016 | openfda |
| Afatinib | US FDA | — | Efficacy supplement 2015-11-09 (see label) | approved | Nov 9, 2015 | openfda |
| Afatinib | US FDA | Lung Non-Small Cell Carcinoma | First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test | approved | Jul 12, 2013 | openfda |
| Afatinib | US FDA | — | Limitations of Use : Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations | approved | Jul 12, 2013 | openfda |
| Afatinib | US FDA | Lung Non-Small Cell Carcinoma | Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy | approved | Jul 12, 2013 | openfda |
| Amivantamab | US FDA | — | Efficacy supplement 2025-08-14 (see label) | approved | Aug 14, 2025 | openfda |
| Amivantamab | US FDA | — | Efficacy supplement 2024-09-19 (see label) | approved | Sep 19, 2024 | openfda |
| Amivantamab | US FDA | — | Efficacy supplement 2024-08-19 (see label) | approved | Aug 19, 2024 | openfda |
| Amivantamab | US FDA | — | Efficacy supplement 2024-03-01 (see label) | approved | Mar 1, 2024 | openfda |
| Amivantamab | US FDA | — | Efficacy supplement 2022-11-04 (see label) | approved | Nov 4, 2022 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | Previously Treated NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT is indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] , whose disease has progressed on or after platinum-based chemotherapy. | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with lazertinib, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | openfda |
| Amivantamab | US FDA | Lung Non-Small Cell Carcinoma | Previously Treated NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor [see Dosage and Administration (2.2) ] . | approved | May 21, 2021 | openfda |
| Carboplatin | US FDA | Ovarian Carcinoma | As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. | approved | Aug 8, 2025 | openfda |
| Carboplatin | US FDA | Ovarian Carcinoma | As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. | approved | Aug 8, 2025 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2021-09-24 (see label) | approved | Sep 24, 2021 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2021-04-06 (see label) | approved | Apr 6, 2021 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2021-04-06 (see label) | approved | Apr 6, 2021 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2012-07-06 (see label) | approved | Jul 6, 2012 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2011-11-07 (see label) | approved | Nov 7, 2011 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2007-10-02 (see label) | approved | Oct 2, 2007 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2006-03-01 (see label) | approved | Mar 1, 2006 | openfda |
| Cetuximab | US FDA | — | Efficacy supplement 2006-03-01 (see label) | approved | Mar 1, 2006 | openfda |
| Cetuximab | US FDA | Head and Neck Squamous Cell Carcinoma | Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. | approved | Feb 12, 2004 | openfda |
| Cetuximab | US FDA | Malignant Colorectal Neoplasm | Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown. ( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. | approved | Feb 12, 2004 | openfda |
| Cetuximab | US FDA | Head and Neck Squamous Cell Carcinoma | Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. | approved | Feb 12, 2004 | openfda |
| Cetuximab | US FDA | Head and Neck Squamous Cell Carcinoma | Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. | approved | Feb 12, 2004 | openfda |
| Cetuximab | US FDA | Malignant Colorectal Neoplasm | Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. | approved | Feb 12, 2004 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2023-09-07 (see label) | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | — | XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2022-07-14 (see label) | approved | Jul 14, 2022 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2021-01-14 (see label) | approved | Jan 14, 2021 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2018-11-30 (see label) | approved | Nov 30, 2018 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2017-04-28 (see label) | approved | Apr 28, 2017 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2016-03-11 (see label) | approved | Mar 11, 2016 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2015-09-14 (see label) | approved | Sep 14, 2015 | openfda |
| Crizotinib | US FDA | — | Efficacy supplement 2013-11-20 (see label) | approved | Nov 20, 2013 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. | approved | Aug 26, 2011 | openfda |
| Crizotinib | US FDA | — | XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. | approved | Aug 26, 2011 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. | approved | Aug 26, 2011 | openfda |
| Dacomitinib | US FDA | Lung Non-Small Cell Carcinoma | VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. ( 1 ) | approved | Sep 27, 2018 | openfda |
| Dacomitinib | US FDA | Lung Non-Small Cell Carcinoma | VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. ( 1 ) | approved | Sep 27, 2018 | openfda |
| Erlotinib | US FDA | — | Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. | approved | Nov 9, 2020 | openfda |
| Erlotinib | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. | approved | Nov 9, 2020 | openfda |
| Erlotinib | US FDA | Lung Non-Small Cell Carcinoma | The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. | approved | Nov 9, 2020 | openfda |