Table 1.
Food and Drug Administration breast cancer NMEs and BLAs approved 2000–2019 (N = 13)
| Brand name | Generic name | NDA or BLAa | Market approval date | Approval designation | Indicated breast cancer typesa |
|---|---|---|---|---|---|
| Faslodex | Fulvestrant | NDA | 04/2002 | Standard | HR+ metastatic breast cancer |
| Tykerb | Lapatinib | NDA | 03/2007 | Priority, Fast track | HER2+ advanced or metastatic breast cancer |
| Ixempra | Ixabepilone | NDA | 10/2007 | Priority | Locally advanced or metastatic breast cancer |
| Halaven | Eribulin mesylate | NDA | 11/2010 | Priority, Fast track | Metastatic breast cancer |
| Perjeta | Pertuzumab | BLA | 06/2012 | Priority | HER2+ metastatic breast cancer |
| Kadcyla | Ado-trastuzumab emtansine | BLA | 02/2013 | Priority, Fast track | HER2+ metastatic breast cancer |
| Ibrance | Palbociclib | NDA | 02/2015 | Priority, Accelerated, Breakthrough | ER+ and HER2- advanced breast cancer |
| Kisqali | Ribociclib | NDA | 03/2017 | Priority, Breakthrough | HR+ and HER2- advanced or metastatic breast cancer |
| Nerlynx | Neratinib | NDA | 07/2017 | Standard | HER2+ early-stage breast cancer |
| Verzenio | Abemaciclib | NDA | 09/2017 | Priority, Breakthrough, Fast track | HR+ and HER2- advanced or metastatic breast cancer |
| Talzenna | Talazoparib | NDA | 10/2018 | Priority | HER2-, germline BRCA mutated locally advanced or metastatic breast cancer |
| Piqray | Alpelisib | NDA | 05/2019 | Priority | HR+, HER2-, PIK3CA mutated, advanced or metastatic breast cancer |
| Enhertu | Fam-trastuzumab deruxtecan-nxki | BLA | 12/2019 | Priority, Accelerated, Breakthrough, Fast track | HER2+ unresectable or metastatic breast cancer |
aExplanation of abbreviations: NDA New drug applications, BLA Biologic license application, HR Hormone receptor, HER2 Human epidermal growth factor receptor 2, ER Estrogen receptor, BRCA Breast cancer susceptibility gene, PIK3CA Catalytic α-subunit of phosphatidylinositol-3-kinase