| 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 | 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 | 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 | 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 |
| 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 | 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 |
| 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 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 | — | 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 | 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 |
| 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 |
| 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 |
| Erlotinib | US FDA | Malignant Pancreatic Neoplasm | First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. | approved | Nov 9, 2020 | 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 | Aug 28, 2015 | 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 | Aug 28, 2015 | openfda |
| Erlotinib | US FDA | — | Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. | approved | Aug 28, 2015 | openfda |
| Erlotinib | US FDA | Malignant Pancreatic Neoplasm | First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. | approved | Aug 28, 2015 | openfda |
| Gefitinib | US FDA | Lung Non-Small Cell Carcinoma | IRESSA is indicated for the first-line 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 [see Clinical Studies (14) ] . Limitation of Use: Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies (14) ] . IRESSA is a tyrosine kinase inhibitor indicated for the first-line 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. (1) Limitation of Use: Safety and efficacy of IRESSA have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations. (1) | approved | Jul 13, 2015 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2025-01-16 (see label) | approved | Jan 16, 2025 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2017-06-29 (see label) | approved | Jun 29, 2017 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2014-05-23 (see label) | approved | May 23, 2014 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2014-05-23 (see label) | approved | May 23, 2014 | openfda |
| Panitumumab | US FDA | — | Efficacy supplement 2008-06-23 (see label) | approved | Jun 23, 2008 | openfda |
| Panitumumab | US FDA | Malignant Colorectal Neoplasm | Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of: Adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) Metastatic Colorectal Cancer (mCRC)*: In combination with FOLFOX for first-line treatment. ( 1 , 14.2 ) As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. ( 1 , 14.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC)* In combination with sotorasib, for the treatment of adult patients with KRAS G12C- mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. ( 1 ) *Limitations of Use: Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown ( 1 , 2.1 , 5.2 , 12.1 , 14.3 ). Metastatic Colorectal Cancer (mCRC) RAS Wild-Type mCRC Vectibix is indicated for the treatment of adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) metastatic colorectal cancer (mCRC) [see Dosage and Administration (2.1) ] : As first-line therapy in combination with FOLFOX [see Clinical Studies (14.2) ] . As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy [see Clinical Studies (14.1) ] . KRAS G12C -mutated mCRC Vectibix, in combination with sotorasib, is indicated for the treatment of adult patients with KRAS G12C- mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy [see Dosage and Administration (2.1) and Clinical Studies (14.4) ] . Limitations of Use : Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown [see Dosage and Administration (2.1) , Warnings and Precautions (5.2) , Clinical Pharmacology (12.1) and Clinical Studies (14.3) ] . | approved | Sep 27, 2006 | openfda |
| Vemurafenib | US FDA | — | Efficacy supplement 2017-11-06 (see label) | approved | Nov 6, 2017 | openfda |
| Vemurafenib | US FDA | — | Efficacy supplement 2017-09-13 (see label) | approved | Sep 13, 2017 | openfda |
| Vemurafenib | US FDA | — | Efficacy supplement 2016-08-31 (see label) | approved | Aug 31, 2016 | openfda |
| Vemurafenib | US FDA | — | Efficacy supplement 2014-03-19 (see label) | approved | Mar 19, 2014 | openfda |
| Vemurafenib | US FDA | Melanoma | ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. | approved | Aug 17, 2011 | openfda |
| Vemurafenib | US FDA | — | ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. | approved | Aug 17, 2011 | openfda |
| Vemurafenib | US FDA | Melanoma | Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 ) | approved | Aug 17, 2011 | openfda |