Biomarker · Gene alteration

EGFR mutation (any sensitizing or resistance mutation)

Somatic mutations of the EGFR tyrosine kinase domain detected by sequencing or PCR in tumor tissue or plasma; used as a predictive marker for EGFR tyrosine kinase inhibitors, chiefly in non-small cell lung cancer.

CI-BIO-00000008EGFR graph →NCIt C98357

Also calledEGFR-mutant · EGFR-mutated · EGFR activating mutation

Derived

Associated cancers (20)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Lung Non-Small Cell Carcinoma	152	149	3	—	28 / 52 / 32 / 39 / 1
Lung Adenocarcinoma	46	44	2	—	1 / 18 / 25 / 2 / 0
Malignant Colorectal Neoplasm	17	17	—	—	0 / 5 / 4 / 7 / 1
Malignant Neoplasm	14	14	—	—	0 / 0 / 0 / 14 / 0
Head and Neck Squamous Cell Carcinoma

Derived

Drugs with predictive evidence (39)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
ErlotinibSmall Molecule	99	78	21	A	71 / 21	Colon Adenocarcinoma, Glioblastoma, High-Grade Glioma, NOS, Lung Adenocarcinoma +6
GefitinibSmall Molecule	69	59	10

Curated evidence

Predictive evidence items (252)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 201–250 of 252 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
EGFR T790M6
Rociletinib

Regulatory

Approvals mentioning the linked drugs (475)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

health-canada-dpd

Clinical trials

Active trials (936)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 468 recruiting · 247 active phase 3 · 3,992 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 901–936 of 936 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02925234	The Drug Rediscovery Protocol (DRUP Trial)(DRUP)	recruiting	Phase 2	1,550	The Netherlands Cancer Institute

Literature

Linked publications (141)

Publications linked to the scope gene(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–25 of 141 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

EGFR T790M resistance mutation in non small-cell lung carcinoma.
· Clin Chim Acta · 2015 · PMID 25668228 · validated civic_curation pubmed
Osimertinib: First Global Approval.
· Drugs · 2016 · PMID 26729184 · validated civic_curation pubmed
Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.
· N Engl J Med · 2017 · PMID 27959700 · validated civic_curation pubmed
U.S. Food and Drug Administration approval summary: Erlotinib for the first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations.
· Oncologist · 2014 · PMID 24868098 · validated

EGFR L858R4
Erlotinib	Lung Small Cell Carcinoma	Predictive	D	Supports Sensitivity Response	2	accepted	EID4293 In an in vitro study using NCI-H3255 cells (EGFR L858R mutation), inhibition of EGFR phosphorylation was used as an assay to determine sensitivity to EGFR tyrosine kinase inhibitors. NCI-H3255 cells d… (full text at CIViC) PMID 24893891 · Cross et al., 2014 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID5922 In an in vitro study performed after identification of the mutation in a malignant peritoneal mesothelioma patient, COS-7 cells expressing EGFR L858R demonstrated increased EGFR phosphotyrosine after … (full text at CIViC) PMID 20942962 · Foster et al., 2010 · Open in CIViC	civic
Dacomitinib + ErlotinibSubstitutes	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID4285 In an in vitro study, a MCF-7 cell line expressing EGFR L858R mutation demonstrated sensitivity to erlotinib or dacomitinib (PF00299804) treatment, compared to MCF-7 cells expressing EGFR wild-type. S… (full text at CIViC) PMID 21132006 · Harada et al., 2011 · Open in CIViC	civic
Erlotinib + Gefitinib + Multikinase Inhibitor AEE788Substitutes	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID3811 EGFR L858R was expressed in Ba/F3 cells which do not contain endogenous EGFR, and conferred growth factor independance to the cells. Cells were plated and treated with 1st generation EGFR inhibitors G… (full text at CIViC) PMID 19147750 · Kancha et al., 2009 · Open in CIViC	civic

EGFR Amplification2
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID911 87 patients with metastatic colorectal cancer treated with cetuximab were retrospectively analyzed for EGFR amplifications by FISH. In multivariate analysis, EGFR amplification predicted response and … (full text at CIViC) PMID 18794099 · Personeni et al., 2008 · Open in CIViC	civic
Cetuximab + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID854 In this meta-analysis (14 studies, 1021 patients), EGFR gene copy number (GCN) was predictive of improved progression free survival (PFS) and overall survival (OS) with cetuximab or panitumumab regard… (full text at CIViC) PMID 24653627 · Shen et al., 2014 · Open in CIViC	civic

EGFR Expression3
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID1572 Patients with refractory colorectal cancer expressing immunohistochemically detectable EGFR were randomly assigned to receive treatment with cetuximab (n=287) or receive supportive care alone (n=285).… (full text at CIViC) PMID 18003960 · Jonker et al., 2007 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	1	accepted	EID1709 57 patients with chemorefractory colorectal cancer expressing EGFR (IHC staining) were treated with single-agent cetuximab in this phase 2 study. Five patients (9%; 95% CI, 3% to 19%) achieved a parti… (full text at CIViC) PMID 14993230 · Saltz et al., 2004 · Open in CIViC	civic
Panitumumab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	accepted	EID1708 463 patients with 1% or more EGFR tumor cell membrane staining, with metastatic CRC progressive after standard chemotherapy were randomized to panitumumab plus best supportive care (BSC, n = 231) or B… (full text at CIViC) PMID 17470858 · Van Cutsem et al., 2007 · Open in CIViC	civic

EGFR S492R4
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	4	accepted	EID717 In-vitro studies found this mutation to confer resistance to cetuximab. 2 of 10 patients studied also harbored EGFR S492R and were resistant to cetuximab therapy. Panitumumab was still active in-vitro… (full text at CIViC) PMID 22270724 · Montagut et al., 2012 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	4	accepted	EID1080 In this preclinical study of the effects of cetuximab, panitumumab or sym004 on various EGFR mutations in colorectal cancer. The S492R mutation was sensitive to Sym004 and panitumumab treatment but re… (full text at CIViC) PMID 26888827 · Sánchez-Martín et al., 2016 · Open in CIViC	civic
Futuximab/Modotuximab Mixture + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID1079 In this preclinical study of cetuximab, panitumumab or sym004 on various EGFR mutations in colorectal cancer. The S492R mutation was sensitive to Sym004 and panitumumab treatment but resistant to cetu… (full text at CIViC) PMID 26888827 · Sánchez-Martín et al., 2016 · Open in CIViC	civic
Panitumumab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	accepted	EID1078 Tumor sequencing in pre- and post-therapy specimens from ten individuals with mCRC who experienced disease progression after a prior response to cetuximab with chemotherapy was performed. The S492R mu… (full text at CIViC) PMID 22270724 · Montagut et al., 2012 · Open in CIViC	civic

EGFR K467T2
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	3	accepted	EID1083 In this preclinical study on the effects of cetuximab, panitumumab or sym004 on various EGFR mutations in colorectal cancer. In NIH3T3 cells expressing EGFR with a K467T mutation, Sym004 and panitumum… (full text at CIViC) PMID 26888827 · Sánchez-Martín et al., 2016 · Open in CIViC	civic
Futuximab/Modotuximab Mixture + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1082 In this preclinical study on the effects of cetuximab, panitumumab or sym004 on various EGFR mutations in colorectal cancer. In NIH3T3 cells expressing EGFR with a K467T mutation, Sym004 and panitumum… (full text at CIViC) PMID 26888827 · Sánchez-Martín et al., 2016 · Open in CIViC	civic

EGFR Mutation3
Erlotinib	Malignant Lung Neoplasm	Predictive	B	Supports Sensitivity Response	2	accepted	EID3864 In advanced-stage (IIIB or IV) non-small cell lung cancer patients treated with erlotinib, patients whose tumors harbored EGFR mutations (n=3) had a higher 12-week progression-free survival rate compa… (full text at CIViC) PMID 22025157 · Ramalingam et al., 2011 · Open in CIViC	civic
Gefitinib	Malignant Lung Neoplasm	Predictive	B	Supports Sensitivity Response	2	accepted	EID2939 In a study of 52 patients with recurrent lung cancer, 27 individuals had EGFR mutation including 2 point mutations in exon 18 (G719A and G1719C), 23 deletions in exon 19, two insertions in exon 19 (I7… (full text at CIViC) PMID 17409929 · Endoh et al., 2006 · Open in CIViC	civic
Cytoreductive Surgery + Hyperthermic Intraperitoneal ChemotherapyCombination	Peritoneal Mesothelial NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID5923 25 patients with metastatic peritoneal mesothelioma were treated with surgical cytoreduction consolidated with intraperitoneal hyperthermic chemotherapy (CRS/IPHC). 8 of the patients carried EGFR muta… (full text at CIViC) PMID 20942962 · Foster et al., 2010 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
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
Nivolumab	EU EMA	—	Melanoma Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1). Non-small cell lung cancer (NSCLC) Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Neoadjuvant treatment of NSCLC Opdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Neoadjuvant and adjuvant treatment of NSCLC Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Malignant pleural mesothelioma (MPM) Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Renal cell carcinoma (RCC) Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1). Classical Hodgkin lymphoma (cHL) Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma. Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Opdivo in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy (see section 5.1). Squamous cell cancer of the head and neck (SCCHN) Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1). Urothelial carcinoma Opdivo in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. Opdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. Adjuvant treatment of urothelial carcinoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle …
Nivolumab	US FDA	Lung Non-Small Cell Carcinoma	adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery.	approved	Dec 22, 2014	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	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	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	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 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	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 Mesylate	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 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 Mesylate	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
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
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02528746) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 8, 2024	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02528754) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 8, 2024	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02517647) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 15, 2022	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02517639) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 15, 2022	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED FOR INJECTION, USP (DIN 02463083) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 17, 2022	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED FOR INJECTION, USP (DIN 02463091) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 17, 2022	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED FOR INJECTION (DIN 02515423) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 10, 2022	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as TARO-PEMETREXED (DIN 02480492) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 7, 2021	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as TARO-PEMETREXED (DIN 02429195) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 18, 2018	health-canada-dpd
Pemetrexed	CA Health Canada	—	Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02438682) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 29, 2017	health-canada-dpd