| 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 | Lung Non-Small Cell Carcinoma | Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy | 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 |
| 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 | 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 | 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 | — | Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. | 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 | 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 | 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 |
| Erlotinib | US FDA | — | Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. | 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 |
| Lapatinib | US FDA | — | Efficacy supplement 2018-12-06 (see label) | approved | Dec 6, 2018 | openfda |
| Lapatinib | US FDA | — | Efficacy supplement 2013-10-18 (see label) | approved | Oct 18, 2013 | openfda |
| Lapatinib | US FDA | — | Efficacy supplement 2013-10-18 (see label) | approved | Oct 18, 2013 | openfda |
| Lapatinib | US FDA | — | Efficacy supplement 2010-01-29 (see label) | approved | Jan 29, 2010 | openfda |
| Lapatinib | US FDA | Malignant Breast Neoplasm | TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. TYKERB is a kinase inhibitor indicated in combination with: ( 1 ) capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. | approved | Mar 13, 2007 | openfda |
| Neratinib | US FDA | — | Efficacy supplement 2021-06-28 (see label) | approved | Jun 28, 2021 | openfda |
| Neratinib | US FDA | — | Efficacy supplement 2020-07-29 (see label) | approved | Jul 29, 2020 | openfda |
| Neratinib | US FDA | — | Efficacy supplement 2020-02-25 (see label) | approved | Feb 25, 2020 | openfda |
| Neratinib | US FDA | — | Efficacy supplement 2020-02-25 (see label) | approved | Feb 25, 2020 | openfda |
| Neratinib | US FDA | — | Efficacy supplement 2019-10-01 (see label) | approved | Oct 1, 2019 | openfda |
| Neratinib | US FDA | HER2-Positive Breast Carcinoma | As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. | approved | Jul 17, 2017 | openfda |
| Neratinib | US FDA | HER2-Positive Breast Carcinoma | In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. | approved | Jul 17, 2017 | openfda |
| Osimertinib | US FDA | — | Efficacy supplement 2024-09-25 (see label) | approved | Sep 25, 2024 | openfda |
| Osimertinib | US FDA | — | Efficacy supplement 2024-02-16 (see label) | approved | Feb 16, 2024 | openfda |
| Osimertinib | US FDA | — | Efficacy supplement 2024-01-31 (see label) | approved | Jan 31, 2024 | openfda |
| Osimertinib | US FDA | — | Efficacy supplement 2020-12-18 (see label) | approved | Dec 18, 2020 | openfda |
| Osimertinib | US FDA | — | Efficacy supplement 2020-12-09 (see label) | approved | Dec 9, 2020 | openfda |
| Osimertinib | US FDA | — | Efficacy supplement 2020-05-23 (see label) | approved | May 23, 2020 | openfda |
| Osimertinib | US FDA | — | Efficacy supplement 2018-04-18 (see label) | approved | Apr 18, 2018 | openfda |
| Osimertinib | US FDA | — | Efficacy supplement 2017-03-30 (see label) | approved | Mar 30, 2017 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib | US FDA | Lung Non-Small Cell Carcinoma | the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | approved | Nov 13, 2015 | openfda |
| Osimertinib Mesylate | US FDA | Lung Non-Small Cell Carcinoma | the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. | approved | Nov 13, 2015 | openfda |
| Pemetrexed | US FDA | — | Efficacy supplement 2025-10-03 (see label) | approved | Oct 3, 2025 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | approved | Jun 28, 2024 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. | approved | Jun 28, 2024 | openfda |
| Pemetrexed | US FDA | Pleural Malignant Mesothelioma | initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. | approved | Jun 28, 2024 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. | approved | Jun 28, 2024 | openfda |
| Pemetrexed | US FDA | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. | approved | Jun 28, 2024 | openfda |
| Pemetrexed | US FDA | Lung Non-Small Cell Carcinoma | Limitations of Use: AXTLE is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | approved | Jun 28, 2024 | openfda |