| 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 | 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 | 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 Hydrochloride | 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 5, 2019 | openfda |
| Gefitinib | CA Health Canada | — | Marketed in Canada as JAMP GEFITINIB (DIN 02500663) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 23, 2020 | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as NAT-GEFITINIB (DIN 02491796) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Dormantsince Mar 1, 2026 | Nov 13, 2019 | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as SANDOZ GEFITINIB (DIN 02487748) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Post Marketsince Jul 31, 2026 | Jun 26, 2019 | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as APO-GEFITINIB (DIN 02468050) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 18, 2017 | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as IRESSA (DIN 02248676) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 17, 2003 | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as EUGIA-GEFITINIB (DIN 02547546) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Gefitinib | CA Health Canada | — | Marketed in Canada as AURO-GEFITINIB (DIN 02533685) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Gefitinib | EU EMA | Lung Non-Small Cell Carcinoma | Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with activating mutations of EGFR TK. | withdrawnsince Sep 27, 2024 | Sep 27, 2018 | ema |
| Gefitinib | EU EMA | Lung Non-Small Cell Carcinoma | Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase. | approved | Jun 24, 2009 | ema |
| 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 | CA Health Canada | — | Marketed in Canada as TYKERB (DIN 02326442) under ATC L01EH01 LAPATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jun 5, 2009 | health-canada-dpd |
| Lapatinib | EU EMA | Malignant Breast Neoplasm | Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting; in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy; in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population. | approved | Jun 10, 2008 | ema |
| 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 |
| Lazertinib | CA Health Canada | — | Marketed in Canada as LAZCLUZE (DIN 02555964) under ATC L01EB09 LAZERTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Apr 28, 2025 | health-canada-dpd |
| Lazertinib | CA Health Canada | — | Marketed in Canada as LAZCLUZE (DIN 02555972) under ATC L01EB09 LAZERTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Apr 28, 2025 | health-canada-dpd |
| Lazertinib | EU EMA | Lung Non-Small Cell Carcinoma | Lazcluze in combination with amivantamab is indicated for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations. | approved | Jan 20, 2025 | ema |
| Lazertinib | US FDA | — | Efficacy supplement 2025-08-14 (see label) | approved | Aug 14, 2025 | openfda |
| Lazertinib | US FDA | Lung Non-Small Cell Carcinoma | LAZCLUZE, in combination with amivantamab, 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 (2.1) ] . LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab 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. ( 1 ) | approved | Aug 19, 2024 | openfda |
| Neratinib | CA Health Canada | — | Marketed in Canada as NERLYNX (DIN 02490536) under ATC L01EH02 NERATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Dec 20, 2019 | health-canada-dpd |
| Neratinib | EU EMA | Malignant Breast Neoplasm | Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. | approved | Aug 31, 2018 | ema |
| 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 | 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 |
| 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 |
| Osimertinib | CA Health Canada | — | Marketed in Canada as TAGRISSO (DIN 02456222) under ATC L01EB04 OSIMERTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 19, 2016 | health-canada-dpd |
| Osimertinib | CA Health Canada | — | Marketed in Canada as TAGRISSO (DIN 02456214) under ATC L01EB04 OSIMERTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jul 19, 2016 | health-canada-dpd |
| Osimertinib | EU EMA | Lung Non-Small Cell Carcinoma | Tagrisso as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum‑based chemoradiation therapy. the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. Tagrisso is indicated in combination with: pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.accelerated | approved | Feb 1, 2016 | ema |
| 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 |