EGFR exon 19 deletion

Clinical trials

Active trials (332)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 153 recruiting · 96 active phase 3 · 1,223 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 332 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
NCT04487080	A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer(MARIPOSA)	active not recruiting

Literature

Linked publications (28)

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

pubmedPublishedShowing 26–28 of 28 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

The impact of human EGFR kinase domain mutations on lung tumorigenesis and in vivo sensitivity to EGFR-targeted therapies.
· Cancer Cell · 2006 · PMID 16730237 · validated civic_curation pubmed
Afatinib is especially effective against non-small cell lung cancer carrying an EGFR exon 19 deletion.
· Anticancer Res · 2015 · PMID 25862853 · validated civic_curation pubmed
In vitro modeling to determine mutation specificity of EGFR tyrosine kinase inhibitors against clinically relevant EGFR mutants in non-small-cell lung cancer.
· Oncotarget · 2015 · PMID 26515464 · validated civic_curation pubmed

EGFR Exon 19 Deletion + EGFR L858R10
Erlotinib	Lung Adenocarcinoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID3791 The phase 3 (EURTAC) study consisted of of 173 non-small cell lung cancer patients who had not had prior chemotherapy for metastatic disease (although adjuvant or neoadjuvant chemotherapy was permitte… (full text at CIViC) PMID 22285168 · Rosell et al., 2012 · Open in CIViC	civic
Amivantamab + Carboplatin + PemetrexedCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID12156 In this phase III trial, 657 patients with locally advanced or metastatic NSCLC (Non-Small Cell Lung Cancer) harbouring EGFR mutations (exon 19 deletions or L858R) were treated with amivantamab plus c… (full text at CIViC) PMID 37879444 · Passaro et al., 2024 · Open in CIViC	civic
Amivantamab + LazertinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID12131 In this trial (MARIPOSA), 1074 patients with Non-Small Cell Lung Cancer harbouring exon 19 deletion or exon 21 L858R substitution were randomized (2:2:1) to receive lazertinib-amivantamab (n=429), osi… (full text at CIViC) PMID 38942080 · Felip et al., 2024 · Open in CIViC	civic
Dacomitinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID11239 In this phase 3, open-label, randomized trial, 452 patients with EGFR mutation-positive non-small cell lung cancer including exon 19 deletions and exon 21 L858R point mutations were randomized into co… (full text at CIViC) PMID 28958502 · Wu et al., 2017 · Open in CIViC	civic
Erlotinib + GefitinibSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID4759 In a study of 1261 non-small cell lung cancer patients, 49.8% of the analyzed tumors had EGFR mutations including deletions in exon 19 (n=258), L858R (n=260), T790M (n=6) and insertions or duplication… (full text at CIViC) PMID 21531810 · Wu et al., 2011 · Open in CIViC	civic
Erlotinib + RamucirumabCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID11240 In this phase 3, randomized, double-blind, placebo-controlled trial, 449 patients stage IV NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations. Patients were randomly assigned in a 1:1 rati… (full text at CIViC) PMID 31591063 · Nakagawa et al., 2019 · Open in CIViC	civic
Gefitinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID11241 In this phase-IV, open-label, single-arm study, 106 patients with NSCLC and EGFR mutations including exon 19 deletion and exon 21 L858R point mutations were administered 250 mg daily doses of gefitini… (full text at CIViC) PMID 24263064 · Douillard et al., 2014 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	4	accepted	EID2156 A phase 2 study of 120 stage IIIB-IV lung adenocarcinoma patients reported improved progression free survival in patients with EGFR mutation (defined as exon 19 deletion or exon 21 mutation) when trea… (full text at CIViC) PMID 24755888 · Yu et al., 2014 · Open in CIViC	civic
Osimertinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID11219 In this phase 3, double-blind trial, 682 patients were randomly assigned 1:1 to either osimertinib (80 mg once daily) or placebo for 3 years following complete resection of EGFR mutation positive (exo… (full text at CIViC) PMID 32955177 · Wu et al., 2020 · Open in CIViC	civic
Chemotherapy + OsimertinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID12015 In this phase 3 clinical trial, 557 patients with NSCLC harbouring EGFR mutations (exon 19 deletion or L858R mutation) were randomly assigned to two groups and treated with either osimertinib with che… (full text at CIViC) PMID 37937763 · Planchard et al., 2023 · Open in CIViC	civic

EGFR Exon 19 Deletion + EGFR L858R10

Erlotinib

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID3791

The phase 3 (EURTAC) study consisted of of 173 non-small cell lung cancer patients who had not had prior chemotherapy for metastatic disease (although adjuvant or neoadjuvant chemotherapy was permitte… (full text at CIViC)

PMID 22285168 · Rosell et al., 2012 · Open in CIViC

Amivantamab + Carboplatin + PemetrexedCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID12156

In this phase III trial, 657 patients with locally advanced or metastatic NSCLC (Non-Small Cell Lung Cancer) harbouring EGFR mutations (exon 19 deletions or L858R) were treated with amivantamab plus c… (full text at CIViC)

PMID 37879444 · Passaro et al., 2024 · Open in CIViC

Amivantamab + LazertinibCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID12131

In this trial (MARIPOSA), 1074 patients with Non-Small Cell Lung Cancer harbouring exon 19 deletion or exon 21 L858R substitution were randomized (2:2:1) to receive lazertinib-amivantamab (n=429), osi… (full text at CIViC)

PMID 38942080 · Felip et al., 2024 · Open in CIViC

Dacomitinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11239

In this phase 3, open-label, randomized trial, 452 patients with EGFR mutation-positive non-small cell lung cancer including exon 19 deletions and exon 21 L858R point mutations were randomized into co… (full text at CIViC)

PMID 28958502 · Wu et al., 2017 · Open in CIViC

Erlotinib + GefitinibSubstitutes

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID4759

In a study of 1261 non-small cell lung cancer patients, 49.8% of the analyzed tumors had EGFR mutations including deletions in exon 19 (n=258), L858R (n=260), T790M (n=6) and insertions or duplication… (full text at CIViC)

PMID 21531810 · Wu et al., 2011 · Open in CIViC

Erlotinib + RamucirumabCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11240

In this phase 3, randomized, double-blind, placebo-controlled trial, 449 patients stage IV NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations. Patients were randomly assigned in a 1:1 rati… (full text at CIViC)

PMID 31591063 · Nakagawa et al., 2019 · Open in CIViC

Gefitinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11241

In this phase-IV, open-label, single-arm study, 106 patients with NSCLC and EGFR mutations including exon 19 deletion and exon 21 L858R point mutations were administered 250 mg daily doses of gefitini… (full text at CIViC)

PMID 24263064 · Douillard et al., 2014 · Open in CIViC

〃

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID2156

A phase 2 study of 120 stage IIIB-IV lung adenocarcinoma patients reported improved progression free survival in patients with EGFR mutation (defined as exon 19 deletion or exon 21 mutation) when trea… (full text at CIViC)

PMID 24755888 · Yu et al., 2014 · Open in CIViC

Osimertinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11219

In this phase 3, double-blind trial, 682 patients were randomly assigned 1:1 to either osimertinib (80 mg once daily) or placebo for 3 years following complete resection of EGFR mutation positive (exo… (full text at CIViC)

PMID 32955177 · Wu et al., 2020 · Open in CIViC

Chemotherapy + OsimertinibCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID12015

In this phase 3 clinical trial, 557 patients with NSCLC harbouring EGFR mutations (exon 19 deletion or L858R mutation) were randomly assigned to two groups and treated with either osimertinib with che… (full text at CIViC)

PMID 37937763 · Planchard et al., 2023 · Open in CIViC

EGFR C797S + EGFR Exon 19 Deletion + EGFR T790M1
Osimertinib	Lung Adenocarcinoma	Predictive	C	Supports Resistance	1	accepted	EID1396 Case report of a patient with stage IV lung adenocarcinoma and a 15–base pair deletion in EGFR exon 19. Partial response with erlotinib was achieved for 15 months after initial chemotherapy. After fur… (full text at CIViC) PMID 26181354 · Yu et al., 2015 · Open in CIViC	civic

EGFR C797S + EGFR Exon 19 Deletion + EGFR T790M1

Osimertinib

Lung Adenocarcinoma

Predictive

Supports Resistance

accepted

EID1396

Case report of a patient with stage IV lung adenocarcinoma and a 15–base pair deletion in EGFR exon 19. Partial response with erlotinib was achieved for 15 months after initial chemotherapy. After fur… (full text at CIViC)

PMID 26181354 · Yu et al., 2015 · Open in CIViC

EGFR Exon 19 Deletion + EGFR T790M2
Osimertinib	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	1	accepted	EID1397 Case report of a patient with stage IV lung adenocarcinoma and a 15–base pair deletion in EGFR exon 19. Partial response with erlotinib was achieved for 15 months after initial chemotherapy. After fur… (full text at CIViC) PMID 26181354 · Yu et al., 2015 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID11598 This phase 3 trial (NCT02151981) involved 419 patients with EGFR T790M mutant NSCLC who progressed after first-line EGFR inhibitor therapy (gefitinib, erlotinib, or afatinib) and were either treated w… (full text at CIViC) PMID 27959700 · Mok et al., 2017 · Open in CIViC	civic

EGFR Exon 19 Deletion + EGFR T790M2

Osimertinib

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID1397

PMID 26181354 · Yu et al., 2015 · Open in CIViC

〃

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11598

This phase 3 trial (NCT02151981) involved 419 patients with EGFR T790M mutant NSCLC who progressed after first-line EGFR inhibitor therapy (gefitinib, erlotinib, or afatinib) and were either treated w… (full text at CIViC)

PMID 27959700 · Mok et al., 2017 · Open in CIViC

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Afatinib	CA Health Canada	—	Marketed in Canada as MAR-AFATINIB (DIN 02517027) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 31, 2025	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as MAR-AFATINIB (DIN 02517019) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 31, 2025	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as MAR-AFATINIB (DIN 02517035) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 31, 2025	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as SANDOZ AFATINIB (DIN 02512777) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 28, 2024	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as SANDOZ AFATINIB (DIN 02512785) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 28, 2024	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as SANDOZ AFATINIB (DIN 02512793) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 28, 2024	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as GIOTRIF (DIN 02415682) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 17, 2014	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as GIOTRIF (DIN 02415666) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 17, 2014	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as GIOTRIF (DIN 02415674) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 17, 2014	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as TEVA-AFATINIB (DIN 02514605) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025	—	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as TEVA-AFATINIB (DIN 02514591) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025	—	health-canada-dpd
Afatinib	CA Health Canada	—	Marketed in Canada as TEVA-AFATINIB (DIN 02514613) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025	—	health-canada-dpd
Afatinib	EU EMA	Lung Non-Small Cell Carcinoma	Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.	approved	Sep 25, 2013	ema
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	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
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
Amivantamab	CA Health Canada	—	Marketed in Canada as RYBREVANT SC (DIN 02569167) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 24, 2026	health-canada-dpd
Amivantamab	CA Health Canada	—	Marketed in Canada as RYBREVANT SC (DIN 02569159) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 24, 2026	health-canada-dpd
Amivantamab	CA Health Canada	—	Marketed in Canada as RYBREVANT SC (DIN 02569140) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 24, 2026	health-canada-dpd
Amivantamab	CA Health Canada	—	Marketed in Canada as RYBREVANT SC (DIN 02569175) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 24, 2026	health-canada-dpd
Amivantamab	CA Health Canada	—	Marketed in Canada as RYBREVANT (DIN 02526182) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 26, 2022	health-canada-dpd
Amivantamab	EU EMA	Lung Non-Small Cell Carcinoma	Rybrevant is indicated: in combination with lazertinib 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. in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). in combination with carboplatin and pemetrexed for the first line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations. as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum based therapy.	approved	Dec 9, 2021	ema
Amivantamab	US FDA	—	Efficacy supplement 2025-08-14 (see label)	approved	Aug 14, 2025	openfda
Amivantamab	US FDA	—	Efficacy supplement 2024-09-19 (see label)	approved	Sep 19, 2024	openfda
Amivantamab	US FDA	—	Efficacy supplement 2024-08-19 (see label)	approved	Aug 19, 2024	openfda
Amivantamab	US FDA	—	Efficacy supplement 2024-03-01 (see label)	approved	Mar 1, 2024	openfda
Amivantamab	US FDA	—	Efficacy supplement 2022-11-04 (see label)	approved	Nov 4, 2022	openfda
Amivantamab	US FDA	Lung Non-Small Cell Carcinoma	First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] .	approved	May 21, 2021	openfda
Amivantamab	US FDA	Lung Non-Small Cell Carcinoma	First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with lazertinib, 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 (2.2) ] .	approved	May 21, 2021	openfda
Amivantamab	US FDA	Lung Non-Small Cell Carcinoma	Previously Treated NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT is indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] , whose disease has progressed on or after platinum-based chemotherapy.	approved	May 21, 2021	openfda
Amivantamab	US FDA	Lung Non-Small Cell Carcinoma	Previously Treated NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor [see Dosage and Administration (2.2) ] .	approved	May 21, 2021	openfda
Aumolertinib	EU EMA	Lung Non-Small Cell Carcinoma	Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (forbiomarker-based patient selection, see section 4.2)	approved	Feb 12, 2026	ema
Carboplatin	CA Health Canada	—	Marketed in Canada as CARBOPLATIN INJECTION BP (DIN 02320371) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 11, 2015	health-canada-dpd
Carboplatin	CA Health Canada	—	Marketed in Canada as CARBOPLATIN INJECTION (DIN 02366053) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Jul 28, 2020	Jun 10, 2013	health-canada-dpd
Carboplatin	CA Health Canada	—	Marketed in Canada as CARBOPLATIN INJECTION BP (DIN 02126680) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 30, 1997	health-canada-dpd
Carboplatin	CA Health Canada	—	Marketed in Canada as CARBOPLATIN INJECTION (DIN 02125439) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1994	health-canada-dpd
Carboplatin	CA Health Canada	—	Marketed in Canada as CARBOPLATIN INJECTION LIQ 10MG/ML (DIN 01990438) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 13, 1998	Dec 31, 1992	health-canada-dpd
Carboplatin	CA Health Canada	—	Marketed in Canada as PARAPLATIN-AQ INJ 10MG/ML (DIN 00788759) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jul 30, 2007	Dec 31, 1989	health-canada-dpd
Carboplatin	CA Health Canada	—	Marketed in Canada as PARAPLATIN INJ 150MG/VIAL (DIN 00680060) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 9, 1996	Dec 31, 1986	health-canada-dpd
Carboplatin	CA Health Canada	—	Marketed in Canada as CARBOPLATIN INJECTION BP (DIN 02570963) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Carboplatin	CA Health Canada	—	Marketed in Canada as CARBOPLATIN INJECTION (DIN 02535289) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Carboplatin	CA Health Canada	—	Marketed in Canada as CARBOPLATIN INJECTION, BP (DIN 02420228) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Carboplatin	CA Health Canada	—	Marketed in Canada as CARBOPLATIN INJECTION (DIN 02528916) under ATC L01XA02 CARBOPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Carboplatin	US FDA	Ovarian Carcinoma	As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma.	approved	Aug 8, 2025	openfda
Carboplatin	US FDA	Ovarian Carcinoma	As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy.	approved	Aug 8, 2025	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

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

CA Health Canada

—

Marketed in Canada as MAR-AFATINIB (DIN 02517027) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 31, 2025

CA Health Canada

—

Marketed in Canada as MAR-AFATINIB (DIN 02517019) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 31, 2025

CA Health Canada

—

Marketed in Canada as MAR-AFATINIB (DIN 02517035) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 31, 2025

CA Health Canada

—

Marketed in Canada as SANDOZ AFATINIB (DIN 02512777) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Oct 28, 2024

CA Health Canada

—

Marketed in Canada as SANDOZ AFATINIB (DIN 02512785) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Oct 28, 2024

CA Health Canada

—

Marketed in Canada as SANDOZ AFATINIB (DIN 02512793) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Oct 28, 2024

CA Health Canada

—

Marketed in Canada as GIOTRIF (DIN 02415682) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 17, 2014

CA Health Canada

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Marketed in Canada as GIOTRIF (DIN 02415666) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 17, 2014

CA Health Canada

—

Marketed in Canada as GIOTRIF (DIN 02415674) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 17, 2014

CA Health Canada

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Marketed in Canada as TEVA-AFATINIB (DIN 02514605) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025

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CA Health Canada

—

Marketed in Canada as TEVA-AFATINIB (DIN 02514591) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025

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CA Health Canada

—

Marketed in Canada as TEVA-AFATINIB (DIN 02514613) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025

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Lung Non-Small Cell Carcinoma

EU EMA

Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.

approved

Sep 25, 2013

ema