Patient-reported outcomes in breast cancer FDA drug labels and review documents

Journal of Patient-Reported Outcomes

Table 1 Food and Drug Administration breast cancer NMEs and BLAs approved 2000–2019 (N = 13)

Brand name	Generic name	NDA or BLA^a	Market approval date	Approval designation	Indicated breast cancer types^a
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