| Erlotinib | US FDA | — | Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. | 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 | 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 |
| 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 |
| Panitumumab | CA Health Canada | — | Marketed in Canada as VECTIBIX (DIN 02308509) under ATC L01FE02 PANITUMUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Jan 3, 2017 | health-canada-dpd |
| Panitumumab | CA Health Canada | — | Marketed in Canada as VECTIBIX (DIN 02308487) under ATC L01FE02 PANITUMUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | May 27, 2008 | health-canada-dpd |
| Panitumumab | CA Health Canada | — | Marketed in Canada as VECTIBIX (DIN 02308495) under ATC L01FE02 PANITUMUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approved | — | health-canada-dpd |
| Panitumumab | EU EMA | Malignant Colorectal Neoplasm | Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): in first-line in combination with Folfox or Folfiri. in second-line in combination with Folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. | approved | Dec 3, 2007 | ema |
| 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 | CA Health Canada | — | Marketed in Canada as ZELBORAF (DIN 02380242) under ATC L01EC01 VEMURAFENIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Mar 5, 2012 | health-canada-dpd |
| Vemurafenib | EU EMA | Melanoma | Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma. | approved | Feb 17, 2012 | ema |
| 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 |