Table 2.
FDA-approved therapeutic drugs for breast cancers
| Drug (brand name) | Sponsor | Properties | Indication | Approval date | Review |
|---|---|---|---|---|---|
| Docetaxel (Taxotere) | Sanofi | Microtubule-stabilizing agent | Locally advanced or metastatic breast cancer | 05/14/1996 | P |
| Ixabepilone (Ixempra) | R-Pharm US | Microtubule-stabilizing agent | Locally advanced or metastatic breast cancer | 10/16/2007 | P |
| Eribulin mesylate (Halaven) | Eisai | Microtubule-destabilizing agent | Locally advanced or metastatic breast cancer | 11/15/2010 | P |
| Capecitabine (Xeloda) | Roche | A prodrug of 5-FU | Metastatic breast cancer | 04/30/1998 | P |
| Epirubicin HCl (Ellence) | Pfizer | DNA topoisomerase II inhibitor | Primary breast cancer with axillary node tumor involvement | 09/15/1999 | P, O |
| Anastrozole (Arimidex) | Ani pharms | Aromatase inhibitor | Advanced breast cancer in postmenopausal women | 12/27/1995 | S |
| Letrozole (Femara) | Novartis | Aromatase inhibitor | Advanced breast cancer | 07/25/1997 | S |
| Exemestane (Aromasin) | Pfizer | Aromatase inhibitor | ER-positive early breast cancer | 10/21/1999 | S, O |
| Toremifene citrate (Fareston) | Kyowa Kirin | ER inhibitor | ER-positive metastatic breast cancer | 05/29/1997 | S, O |
| Fulvestrant (Faslodex) | AstraZeneca | ER antagonist | HR-positive metastatic breast cancer | 04/25/2002 | S |
| Palbociclib (Ibrance) | Pfizer | CDK4/6 inhibitor | HER2-negative and HR-positive advanced or metastatic breast cancer | 02/03/2015 | P |
| Ribociclib succinate (Kisqali) | Novartis | CDK4/6 inhibitor | HR-positive, HER2-negative breast cancer | 03/13/2017 | P |
| Abemaciclib (Verzenio) | Eli Lilly | CDK4/6 inhibitor | HR-positive, HER2-negative breast cancer | 09/28/2017 | P |
| Trastuzumab (Herceptin) | Genentech | HER2-directed mAb | HER2-positive breast cancer | 09/25/1998 | P |
| Pertuzumab (Perjeta) | Genentech | HER2‑directed mAb | HER2‑positive metastatic breast cancer | 06/08/2012 | P |
| Margetuximab (Margenza) | MacroGenics | HER2-directed mAb | HER2-positive breast cancer | 12/16/2020 | S |
| Ado-trastuzumab emtansine (Kadcyla) | Genentech | HER2‑directed ADC | HER2‑positive metastatic breast cancer | 02/22/2013 | P |
| Trastuzumab deruxtecan (Enhertu) | Daiichi Sankyo | HER2-directed ADC | HER2-positive breast cancer | 12/20/2019 | P |
| Lapatinib ditosylate (Tykerb) | Novartis | HER2 and EGFR inhibitor | Advanced or metastatic breast cancer | 03/13/2007 | P |
| Neratinib maleate (Nerlynx) | Puma Biotech | EGFR, HER2, and HER4 inhibitor | HER2-overexpressed breast cancer | 07/17/2017 | S |
| Tucatinib (Tukysa) | Seagen | HER2 inhibitor | HER2-positive breast cancer | 04/17/2020 | P, O |
| Talazoparib tosylate (Talzenna) | Pfizer | PARP inhibitor | BRCA-mutated HER2-negative breast cancer | 10/16/2018 | P |
| Alpelisib (Piqray) | Novartis | PI3Kα inhibitor | PIK3CA-altered, HR-positive, and HER2-negative breast cancer | 05/24/2019 | P |
| Sacituzumab govitecan (Trodelvy) | Immunomedics | Trop-2-directed ADC | Triple-negative breast cancer (TNBC) | 04/22/2020 | P |
BRCA: Breast cancer susceptibility gene; CDK4/6 Cyclin-dependent kinases 4/6; ER Estrogen receptor; HER2/4 Human epidermal growth factor receptor 2/4; HR Hormone receptor; O Orphan; P Priority; PARP Poly (ADP-ribose) polymerase; PI3Kα Phosphatidylinositol 3-kinase α; S Standard; TKI Tyrosine kinase inhibitor