Table 1.
Food and Drug Administration (FDA) approved targeted therapies for tumors that have an associated biomarker.
| Preferred Name |
Direct drug Target | Company | FDA Approved Indication - Disease(s) |
FDA Approved Indication - Biomarker(s) |
|---|---|---|---|---|
| Abemaciclib | CDK4, CDK6 | Eli Lilly and Company | Breast cancer | ER Positive, PR Positive, HER2 Negative |
| Afatinib | EGFR | Boehringer Ingelheim | Non-small cell lung carcinoma | EGFR Deletion Exon 19, EGFR L858R |
| Alectinib | EML4-ALK, ALK, INSR, RET | Genentech | Non-small cell lung carcinoma | ALK Fusion |
| Anastrozole | Aromatase | AstraZeneca Pharmaceuticals | Breast cancer | ER Positive, PR Positive |
| Bosutinib | ABL1, BCR-ABL1, SRC | Pfizer | Chronic myelogenous leukemia | BCR-ABL1 |
| Brigatinib | ALK, CSF1R, INSR, ABL1, LCK, IGF1R, CAMK2G, FLT4, RET, FGFR1, FGFR2, FGFR3, AURKA, JAK2, FGFR4, FYN, HCK, LYN, SRC, EGFR, EML4-ALK, FER, FES, FLT3, FPS, ROS1, TYK2, YES1, PTK2B, HER4, CAMK2D, CHEK1, CHEK2 | Ariad Pharmaceuticals | Non-small cell lung carcinoma | ALK Fusion |
| Ceritinib | NPM-ALK, ROS1 Fusion, ALK, INSR, IGF1R, TSSK3, FLT3, FGFR2, RET, FGFR3, LCK, JAK2, AURKA, LYN, EGFR, FGFR4 | Novartis Pharmaceuticals | Non-small cell lung carcinoma | ALK Fusion |
| Cetuximab | EGFR | Eli Lilly and Company | Colorectal cancer | KRAS Wildtype, EGFR Positive |
| Cobimetinib | MAP2K1 | F. Hoffmann-La Roche | Melanoma | BRAF V600E, BRAF V600K |
| Crizotinib | ALK, MET, ROS1, NTRK1 | Pfizer | Non-small cell lung carcinoma | ALK Fusion |
| Pfizer | Non-small cell lung carcinoma | ROS1 Positive | ||
| Dabrafenib | BRAF, RAF1 | GlaxoSmithKline | Melanoma | BRAF V600E |
| GlaxoSmithKline | Melanoma | BRAF V600E, BRAF V600K | ||
| GlaxoSmithKline | Non-small cell lung carcinoma | BRAF V600E | ||
| Dasatinib | ABL1, KIT, BRAF, BCR-ABL1, ABL2, PDGFRA, PDGFRB, SRC, DDR1, DDR2, EPHA3 Amplification, EPHA2, FYN, LCK, LYN, YES1 | Bristol-Myers Squibb | Chronic myelogenous leukemia | BCR-ABL1 |
| Acute lymphoblastic leukemia | BCR-ABL1 | |||
| Enasidenib | IDH2 | Agios Pharmaceuticals | Acute myeloid leukemia | IDH2 Mutation |
| Erlotinib | EGFR | Genentech | Non-small cell lung carcinoma | EGFR Deletion Exon 19, EGFR L858R |
| Everolimus | MTOR | Novartis Pharmaceuticals | Breast cancer | ER Positive, PR Positive, HER2 Negative |
| Exemestane | Aromatase | Pfizer | Breast cancer | ER Positive |
| Fulvestrant | ER | AstraZeneca Pharmaceuticals | Breast cancer | ER Positive, PR Positive, HER2 Negative |
| Breast cancer | ER Positive, PR Positive | |||
| Gefitinib | EGFR | AstraZeneca Pharmaceuticals | Non-small cell lung carcinoma | EGFR Deletion Exon 19, EGFR L858R |
| Gemtuzumab Ozogamicin | CD33 | Pfizer | Acute myeloid leukemia | CD33 Positive |
| Ibrutinib | TEC, ABL1, FYN, RIPK2, SRC, LYN, PDGFRA, HER2, BTK, EGFR, BLK, BMX, CSK, FGR, PTK6, HCK, YES1, ITK, JAK3, FRK, LCK, RET, FLT3 | Janssen Biotech|Pharmacyclics | Small lymphocytic lymphoma, Chronic lymphocytic leukemia | c.CHR17p Deletion |
| Imatinib | PDGFRA, KIT, BCR-ABL1, ABL1, PDGFRB | Novartis Pharmaceuticals | Gastrointestinal Stromal Tumors | KIT Positive |
| Chronic myeloid leukemia, Acute lymphoblastic leukemia, | BCR-ABL1 | |||
| Myelodysplastic/myeloproliferative diseases | PDGFRA Fusion | |||
| Chronic eosinophilic leukemia | FIP1L1-PDGFRA | |||
| Lapatinib | EGFR, HER2, HER4 | Novartis Pharmaceuticals | Breast cancer | HER2 Positive |
| Breast cancer | ER Positive, PR Positive, HER2 Positive | |||
| Letrozole | Aromatase | Novartis Pharmaceuticals | Breast cancer | ER Positive, PR Positive |
| Midostaurin | KDR, FLT3, PDGFRA, PDGFRB, SYK, AKT1, FLT1, AKT2, AKT3, KIT, SRC, PRKCA, PRKCB, PRKCG, CDK1, FGR, ETV6-NTRK3 | Novartis Pharmaceuticals | Acute myeloid leukemia | FLT3 Mutation |
| Neratinib | HER2, EGFR, KDR | Puma Biotechnology, Inc. | Breast cancer | HER2 Overexpression, HER2 Amplification |
| Nilotinib | BCR-ABL1 | Novartis Pharmaceuticals | Chronic myelogenous leukemia | BCR-ABL1 |
| Olaparib | PARP1, PARP2 | AstraZeneca Pharmaceuticals | Ovarian cancer | BRCA1 (any deleterious), BRCA2 (any deleterious) |
| Osimertinib | EGFR, EGFR T790M, EGFR Exon 19 deletion | AstraZeneca Pharmaceuticals | Non-small cell lung carcinoma | EGFR T790M |
| Palbociclib | CDK4, CDK6 | Pfizer | Breast cancer | ER Positive, PR Positive, HER2 Negative |
| Panitumumab | EGFR | Amgen | Colorectal cancer | KRAS Wildtype, NRAS Wildtype |
| Pertuzumab | HER2 | Genentech | Breast cancer, Inflammatory breast cancer | HER2 Positive |
| Ponatinib | PDGFRA, KDR, SRC, ABL1, FGFR1, BCR-ABL1, KIT, RET | Ariad Pharmaceuticals | Acute lymphoblastic leukemia /lymphoblastic lymphoma, Chronic myeloid leukemia | BCR-ABL1 T315I |
| Chronic myeloid leukemia, Acute lymphoblastic leukemia | BCR-ABL1 | |||
| Ribociclib | CDK4, CDK6 | Novartis Pharmaceuticals | Breast cancer | ER Positive, PR Positive, HER2 Negative |
| Rituximab | CD20 | Genentech | Non-Hodgkin's lymphoma, Chronic lymphocytic leukemia | CD20 Positive |
| Rucaparib | PARP1 | Clovis Oncology | Ovarian cancer | BRCA1 (any deleterious), BRCA2 (any deleterious) |
| Tamoxifen | ER | AstraZeneca Pharmaceuticals | Breast cancer | ER Positive (may help predict whether therapy will be beneficial) |
| Trametinib | MAP2K1, MAP2K2 | GlaxoSmithKline | Melanoma | BRAF V600E, BRAF V600K |
| Non-small cell lung carcinoma | BRAF V600E | |||
| Trastuzumab | HER2 | Genentech | Breast cancer, Gastric cancer, Gastroesophageal junction | HER2 Positive |
| Trastuzumab Emtansine | HER2, p.Tubulin | Genentech | Breast cancer | HER2 Positive |
| Vemurafenib | BRAF V600E | F. Hoffmann- La Roche | Melanoma | BRAF V600E |
| Venetoclax | BCL2 | AbbVie | Chronic lymphocytic leukemia | c.CHR17p Deletion |