FDA-Approved Oncology Therapies

Content current as of 02/25/2025
The following US Food and Drug Administration (FDA)-approved oncology drugs post June 1998 are categorized by drug class and mechanism of action. Each drug is further classified as to whether it qualifies as a targeted therapy or precision oncology therapy based on Suehnholz et al., Cancer Discovery 2023 (definitions below).
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Showing 110 therapies: (109 Targeted therapies, 110 Precision oncology therapies, 89 therapies with a biomarker that can be identified by a DNA/NGS-based detection method)
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Year of drug’s first FDA-approval
FDA-approved drug(s)
FDA drug label listed biomarker(s)
Class of agent(s)
Mechanism of action or drug target
Targeted therapy
Precision oncology therapy
Can a DNA/NGS-based method be used for biomarker detection?
2025
Mirdametinib
NF1 Oncogenic Mutations
Small molecule kinase inhibitor
MEK1/2 inhibitor
Y
2025
Datopotamab deruxtecan
HR+/HER2-
Antibody drug conjugate
TROP2-directed antibody and topoisomerase inhibitor conjugate
N
2025
Sotorasib + Panitumumab
KRAS G12C
Small molecule inhibitor and monoclonal antibody combination
KRAS G12C inhibitor + Anti-EGFR antibody
Y
2024
Ensartinib
ALK+ (ALK Fusions)
Multikinase inhibitor
Multi-targeted receptor tyrosine kinase inhibitor (targets include ALK, ROS1 and MET)
Y
2024
Zenocutuzumab
NRG1 Fusion
Bispecific T-cell engager
Bispecific HER2/HER3-directed T-cell engager
Y
2024
Zanidatamab
HER2+ (ERBB2 Amplification)
Monoclonal antibody
Anti-HER2 (ERBB2) antibody
Y
2024
Revumenib
KMT2A Rearrangement
Small molecule inhibitor
Menin inhibitor
Y
2024
Zolbetuximab
HER2- and CLDN18.2+
Monoclonal antibody
CDLN18.2-directed cytolytic antibody
N
2024
Adagrasib + Cetuximab
KRAS G12C
Small molecule inhibitor and monoclonal antibody combination
KRAS G12C inhibitor + Anti-EGFR antibody
Y
2024
Inavolisib + Fulvestrant + Palbociclib
PIK3CA Oncogenic Mutations, HR+/HER2-
Small molecule inhibitor and hormone therapy combination
α-specific PI3K inhibitor + selective estrogen receptor degrader + CDK4/6 inhibitor
Y
2024
Lazertinib + Amivantamab
EGFR L858R, Exon 19 Deletions
Small molecule kinase inhibitor and monoclonal antibody combination
EGFR tyrosine kinase inhibitor + EGFR-MET bispecific antibody
Y
2024
Vorasidenib
IDH1 R132H/C/G/S/L, IDH2 R172K/M/W/S/G
Small molecule inhibitor
IDH1/IDH2 inhibitor
Y
2024
Afamitresgene autoleucel
HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and MAGE-A4 antigen positive
T cell receptor (TCR) therapy
MAGE-A4-directed TCR therapy
N
2024
Tovorafenib
BRAF Fusions, BRAF Rearrangement, BRAF V600
Small molecule kinase inhibitor
RAF inhibitor
Y
2023
Quizartinib
FLT3 ITD Mutations
Small molecule inhibitor
FLT3 inhibitor
Y
2023
Elacestrant
  • ESR1 Ligand-binding domain missense mutations and
  • ER+/HER2-
Hormone therapy
Selective estrogen receptor degrader (SERD)
Y
2023
Capivasertib
PIK3CA, AKT1 or PTEN Oncogenic Mutations and HR+/HER2-
Small molecule kinase inhibitor
AKT1/2/3 inhibitor
Y
2023
Repotrectinib
  • *ROS1 Fusions
  • *NTRK Fusions
Small molecule kinase inhibitor
Multi-targeted kinase inhibitor (targets include ROS1 and NTRK1/2/3)
Y
2022
Tebentafusp
HLA-A*02:01-positivity
Bispecific T-cell engager
Bispecific gp100 peptide-HLA-A*02:01-directed T-cell receptor CD3 T cell engager
N
2022
Pluvicto
PSMA+
Radiotherapy
Radioligand therapeutic agent
N
2022
Olutasidenib
IDH1 R132C/G/H/L/S
Small molecule inhibitor
IDH1 inhibitor
Y
2022
Mirvetuximab soravtansine
FRɑ
Antibody drug conjugate
Folate receptor alpha-directed antibody microtubule inhibitor conjugate
N
2022
Futibatinib
FGFR2 Fusions
Small molecule kinase inhibitor
FGFR1/2/3 inhibitor
Y
2022
Adagrasib
KRAS G12C
Small molecule inhibitor
KRAS G12C inhibitor
Y
2021
Trastuzumab + Pembrolizumab
HER2+ (ERBB2 Amplification)
Monoclonal antibody and immune checkpoint inhibitor combination
Anti-HER2 (ERBB2) antibody + Anti-PD-1 antibody
Y
2021
Tepotinib
MET Exon 14 Skipping Mutations
Small molecule kinase inhibitor
MET inhibitor
Y
2021
Sotorasib
KRAS G12C
Small molecule inhibitor
KRAS G12C inhibitor
Y
2021
Mobocertinib
EGFR Exon 20 Insertions
Small molecule kinase inhibitor
EGFR Exon 20 inhibitor
Y
2021
Infigratinib
FGFR2 Fusions
Small molecule kinase inhibitor
FGFR1/2/3 inhibitor
Y
2021
Dostarlimab
*dMMR *dMMR or MSI-H
Immune checkpoint inhibitor
Anti PD-1 antibody
Y
2021
Belzutifan
VHL Oncogenic Mutations
Small molecule inhibitor
HIF-2ɑ inhibitor
Y
2021
Asciminib
  • Ph+ (BCR-ABL1 Fusion)
  • or ABL1 T315I
Small molecule kinase inhibitor
ABL/BCR-ABL1 tyrosine kinase inhibitor
Y
2021
Amivantamab
  • *EGFR Exon 20 Insertions
  • *EGFR Exon 19 Deletions, L858R
Monoclonal antibody
EGFR-MET bispecific antibody
Y
2020
Tucatinib + Trastuzumab
  • *HER2+ (ERBB2 Amplifiaction)
  • *KRAS and NRAS Wildtype and HER2+ (ERBB2 Amplification)
Small molecule inhibitor and monoclonal antibody combination
HER2 (ERBB2) inhibitor + Anti-HER2 (ERBB2) antibody
Y
2020
Tazemetostat
  • *EZH2 Y646F, A692V, Y646C, Y646S, Y646N, Y646H, A682G
  • *SMARCB1 Deletion
Small molecule inhibitor
EZH2 inhibitor (methyltransferase inhibitor)
Y
2020
Selumetinib
NF1 Oncogenic Mutations
Small molecule kinase inhibitor
MEK1/2 inhibitor
Y
2020
Selpercatinib
RET Fusions and Oncogenic Mutations
Small molecule kinase inhibitor
RET inhibitor (also reported to inhibit other kinases including VEGFR1/2/3 and FGFR1/2/3)
Y
2020
Sacituzumab govitecan
HR+/HER2-
Antibody drug conjugate
TROP2-directed antibody and topoisomerase inhibitor conjugate
N
2020
Ripretinib
KIT/PDGFRA inhibitor
Small molecule kinase inhibitor
KIT/PDGFRA D816
Y
2020
Pralsetinib
RET Fusions and Oncogenic Mutations
Small molecule kinase inhibitor
RET inhibitor (also reported to inhibit other kinases including DDR1, NTRK3, FLT3 and FGFR1/2 among others)
Y
2020
Pemigatinib
  • *FGFR2 Fusions
  • *FGFR1 Fusions
Small molecule kinase inhibitor
FGFR1/2/3 inhibitor
Y
2020
Margetuximab
HER2+ (ERBB2 Amplification)
Monoclonal antibody
Anti-HER2 (ERBB2) antibody
Y
2020
Encorafenib + Cetuximab
BRAF V600E
Small molecule inhibitor and monoclonal antibody combination
BRAF inhibitor + Anti-EGFR antibody
Y
2020
Capmatinib
MET Exon 14 Skipping Mutations
Small molecule kinase inhibitor
MET inhibitor
Y
2020
Atezolizumab + Vemurafenib + Cobimetinib
BRAF V600
Small molecule inhibitor and immune checkpoint inhibitor combination
Anti-PDL-1 antibody + BRAF inhibitor + MEK1/2 inhibitor
Y
2020
Avapritinib
  • *PDGFRA Exon 18 Mutations
  • *KIT D816
Small molecule kinase inhibitor
Multi-targeted kinase inhibitor (targets include KIT D816V, PDGFRA, PDGFRA D842, KIT exon 11, 11/17 and 17 mutants)
Y
2019
Trastuzumab deruxtecan
  • *HER2+ (ERBB2 Amplification)
  • *HER2-low
  • *ERBB2 Oncogenic Mutations
  • *HR+/HER2-low or HER2-ultralow
Antibody drug conjugate
HER2 (ERBB2)-directed antibody and topoisomerase inhibitor conjugate
Y
2019
Alpelisib + Fulvestrant
PIK3CA E545G, Q546E, E545A, H1047R, C420R, H1047Y, Q546R, H1047L, E542K, E545D, E545K
Small molecule inhibitor and hormone therapy combination
α-specific PI3K inhibitor + selective estrogen receptor degrader (SERD)
Y
2019
Entrectinib
  • *NTRK1, NTRK2, NTRK3 Fusions
  • *ROS1 Fusions
Small molecule kinase inhibitor
Multi-targeted kinase inhibitor (targets include NTRK1/2/3, ROS1 and ALK among others)
Y
2019
Erdafitinib
FGFR3-TACC3 Fusion, FGFR3-BAIAP2L1 Fusion, FGFR3 S249C, R248C, G370C, Y373C
Small molecule kinase inhibitor
Multi-targeted kinase inhibitor (targets include FGFR1/2/3/4 among others)
Y
2018
Gilteritinib
FLT3 ITD Mutations, TKD Mutations I836 and D835
Small molecule kinase inhibitor
Multi-targeted tyrosine kinase inhibitor (targets include mutant and WT FLT3, AXL and ALK)
Y
2018
Talazoparib
  • *BRCA1, BRCA2 Oncogenic Mutations
  • *ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11, NBN, PALB2, RAD51C
  • Oncogenic Mutations
Small molecule inhibitor
PARP inhibitor
Y
2018
Lutetium Lu 177 dotatate
Somatostatin Receptor
Hormone therapy
Radiolabeled somatostatin analog
N
2018
Larotrectinib
NTRK1, NTRK2, NTRK3 Fusions
Small molecule kinase inhibitor
NTRK1/2/3 inhibitor
Y
2018
Ivosidenib
IDH1 R132C/G/H/L/S
Small molecule inhibitor
IDH1 inhibitor
Y
2018
Dacomitinib
EGFR L858R, Exon 19 Deletions
Small molecule kinase inhibitor
EGFR tyrosine kinase inhibitor
Y
2018
Cemiplimab
PD-L1-expressing
Immune checkpoint inhibitor
Anti-PD-1 antibody
N
2018
Encorafenib + Binimetinib
BRAF V600E/K
Small molecule kinase inhibitor combination
BRAF inhibitor + MEK1/2 inhibitor
Y
2018
Lorlatinib
ALK+ (ALK Fusions)
Small molecule kinase inhibitor
Multi-targeted kinase inhibitor (targets include ALK and ROS1 among others)
Y
2017
Ribociclib
HR+/ HER2-
Small molecule kinase inhibitor
CDK4/6 inhibitor
Y
2017
Niraparib
BRCA1, BRCA2 Oncogenic Mutations
Small molecule inhibitor
PARP inhibitor
Y
2017
Neratinib
HER2+ (ERBB2 Amplification)
Small molecule kinase inhibitor
EGFR//HER2 (ERBB2)/HER4 (ERBB4) inhibitor
Y
2017
Inotuzumab Ozogamicin
CD22+
Hematopoietic protein binding antibody, ADC or cytotoxin
CD22-directed antibody-drug conjugate
N
2017
Enasidenib
IDH2 R140Q/L/G/W, R172G/K/M/S/W
Small molecule inhibitor
IDH2 inhibitor
Y
2017
Durvalumab
dMMR
Immune checkpoint inhibitor
Anti-PDL-1 antibody
N
2017
Brigatinib
ALK+ (ALK Fusions)
Small molecule kinase inhibitor
ALK inhibitor
Y
2017
Abemaciclib
HR+/ HER2-
Small molecule kinase inhibitor
CDK4/6 inhibitor
N
2017
Midostaurin
FLT3 ITD Mutations, TKD Mutations I836 and D835
Multikinase inhibitor
Multi-targeted kinase inhibitor (targets include FLT3, VEGFR2, KIT and PDGFR)
Y
2016
Rucaparib
BRCA1, BRCA2 Oncogenic Mutations
Small molecule inhibitor
PARP inhibitor
Y
2016
Atezolizumab
PD-L1-expressing
Immune checkpoint inhibitor
Anti-PD-L1 antibody
N
2015
Palbociclib
HR+/ HER2-
Small molecule kinase inhibitor
CDK4/6 inhibitor
N
2015
Osimertinib
EGFR T790M, L858R, Exon 19 Deletions
Small molecule kinase inhibitor
EGFR tyrosine kinase inhibitor with T790M
Y
2015
Ipilimumab + Nivolumab
  • *MSI-H or dMMR
  • *PD-L1-expressing
Immune checkpoint inhibitor
Anti-CTLA-4 antibody + Anti-PD1 antibody
Y
2015
Vemurafenib + Cobimetinib
BRAF V600E/K
Small molecule kinase inhibitor combination
BRAF inhibitor + MEK1/2 inhibitor
Y
2015
Alectinib
ALK+ (ALK Fusions)
Small molecule kinase inhibitor
ALK inhibitor
Y
2014
Pembrolizumab
  • *MSI-H or dMMR
  • *TMB-H
  • *PD-L1-expressing
  • *pMMR
Immune checkpoint inhibitor
Anti-PD-1 antibody
Y
2014
Olaparib
  • *BRCA1, BRCA2 Oncogenic Mutations
  • *ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54 Oncogenic Mutations
Small molecule inhibitor
PARP inhibitor
Y
2014
Nivolumab
MSI-H
Immune checkpoint inhibitor
Anti-PD-1 antibody
Y
2014
Dabrafenib + Trametinib
BRAF V600E/K
Small molecule kinase inhibitor combination
BRAF inhibitor + MEK1/2 inhibitor
Y
2014
Ceritinib
ALK+ (ALK Fusions)
Small molecule kinase inhibitor
ALK inhibitor
Y
2014
Blinatumomab
CD19+
Bispecific T-cell engager
Bispecific CD19-directed CD3 T-cell engager
N
2013
Trametinib
BRAF V600E/K
Small molecule kinase inhibitor
MEK1/2 inhibitor
Y
2013
Ibrutinib
17p del
Small molecule kinase inhibitor
BTK inhibitor
Y
2013
Dabrafenib
BRAF V600E/K
Small molecule kinase inhibitor
BRAF inhibitor
Y
2013
Afatinib
EGFR L858R, G719X, L861Q, S768I, Exon 19 Deletions
Small molecule kinase inhibitor
EGFR tyrosine kinase inhibitor
Y
2013
Ado-trastuzumab emtansine
HER2+ (ERBB2 Amplification)
Antibody drug conjugate
HER2 (ERBB2)-directed antibody and microtubule inhibitor conjugate
Y
2012
Regorafenib
KIT+
Multikinase inhibitor
Multi-targeted tyrosine kinase inhibitor (targets include KIT, RET, VEGFR1/2/3, FGFR1/2, PDGFRβ among others)
Y
2012
Ponatinib
  • Ph+ (BCR-ABL1 Fusion) or
  • ABL1 T315I
Multikinase inhibitor
Multi-targeted tyrosine kinase inhibitor (targets include BCR-ABL1, VEGFR, PDGFR, FGFR and SRC family members among others)
Y
2012
Bosutinib
Ph+ (BCR-ABL1 Fusion)
Multikinase inhibitor
Multi-targeted tyrosine kinase inhibitor (targets include BCR-ABL1 and SRC family kinases)
Y
2012
Pertuzumab + Trastuzumab
HER2+ (ERBB2 Amplification)
Monoclonal antibody combination
Anti-HER2 (ERBB2) antibody + Anti-HER2 (ERBB2) antibody
Y
2011
Crizotinib
  • *ALK+ (ALK Fusions)
  • *ROS1+ (ROS1 Fusions)
Multikinase inhibitor
Multi-targeted receptor tyrosine kinase inhibitor (targets include ALK, ROS1 and MET)
Y
2011
Vemurafenib
BRAF V600
Small molecule kinase inhibitor
BRAF inhibitor
Y
2011
Brentuximab vedotin
CD30+
Hematopoietic protein binding antibody, ADC or cytotoxin
CD30-directed antibody-drug conjugate
N
2009
Everolimus
TSC1, TSC2 Oncogenic Mutations
Large molecule inhibitor
mTOR inhibitor
Y
2007
Nilotinib
Ph+ (BCR-ABL1 Fusion)
Multikinase inhibitor
Multi-targeted tyrosine kinase inhibitor (targets include BCR-ABL1, PDGFR and KIT among others)
Y
2007
Lapatinib
HER2 Overexpression (ERBB2 Amplification)
Small molecule kinase inhibitor
Dual tyrosine kinase inhibitor (targets EGFR and ERBB2)
Y
2006
Sunitinib
KIT+
Multikinase inhibitor
Multi-targeted receptor tyrosine kinase inhibitor (targets include VEGFR1/2/3, KIT, FLT3, CSF1R and PDGFRɑ/β among others)
Y
2006
Dasatinib
Ph+ (BCR-ABL1 Fusion)
Multikinase inhibitor
Multi-targeted kinase inhibitor (targets include SRC, BCR-ABL1, KIT and PDGFRβ among others)
Y
2006
Panitumumab
KRAS and NRAS Wildtype and EGFR-expressing
Monoclonal antibody
Anti-EGFR antibody
Y
2004
Erlotinib
EGFR L858R, Exon 19 Deletions
Small molecule kinase inhibitor
EGFR tyrosine kinase inhibitor
Y
2004
Cetuximab
KRAS Wildtype and EGFR-expressing
Monoclonal antibody
Anti-EGFR antibody
Y
2003
Tositumomab and Iodine I 131 Tositumomab
CD20+
Hematopoietic protein binding antibody, ADC or cytotoxin
Anti-CD20 antibody
N
2003
Gefitinib
EGFR L858R, Exon 19 Deletions
Small molecule kinase inhibitor
EGFR tyrosine kinase inhibitor
Y
2002
Fulvestrant
HR+/ HER2-
Hormone therapy
Selective estrogen receptor degrader (SERD)
N
1998-2001
Imatinib
  • *Ph+ (BCR-ABL1 Fusion)
  • *KIT+
  • *PDGFRA, PDGFRB Fusions
  • *PDGFB Fusions
  • *FIP1L1-PDGFRA fusion
Multikinase inhibitor
Multi-targeted kinase inhibitor (targets include BCR-ABL, KIT, PDGFRA)
Y
1998-2001
Trastuzumab
HER2+ (ERBB2 Amplification)
Monoclonal antibody
Anti-HER2 (ERBB2) antibody
Y
1998-2001
Gemtuzumab ozogamicin
CD33+
Hematopoietic protein binding antibody, ADC or cytotoxin
Anti-CD33 antibody
N
1998-2001
Exemestane
ER+
Hormone therapy
Aromatase inhibitor
N
1998-2001
Denileukin diftitox
CD25+
Hematopoietic protein binding antibody, ADC or cytotoxin
CD25-directed cytotoxin
N
1998-2001
Arsenic trioxide
PML-RARɑ Fusion
Cytotoxic chemotherapy
Chemotherapeutic agent; targets PML-RARɑ
Y
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