Table 1. Time to anti-HER2 regulatory approval in FDA and Brazil.

Drug/indication	FDA approval (year)	ANVISA approval (year)	SUS access authorization (year)
Trastuzumab/metastatic	1998	1999	2017
Trastuzumab/adjuvant	2005	2006	2012
Lapatinib/metastatic	2007	2007	Unavailable
Pertuzumab/metastatic	2012	2013	2017
Pertuzumab/neoadjuvant	2013	2016	Unavailable
Pertuzumab/adjuvant	2017	2018	Unavailable
TDM1 metastatic	2013	2014	Unavailable

Legend: FDA Food and drug Administration (US), ANVISA Agência Nacional de Vigilância Sanitária (Brazil), SUS Sistema Público de Saúde (Brazil).