Table 1. Therapeutic antibody-based therapeutics in first regulatory review in US, EU or Japan.

Sponsoring company	Name	Molecular format	Target	Location of regulatory review	Designations	Indication under review
Novartis	Secukinumab	Human IgG1	IL-17a	US, EU	S	Psoriasis
United Therapeutics Europe Ltd	Dinutuximab	Chimeric IgG1	GD2	EU	O (EU, US)	Brain cancer
Ono Pharma./Bristol-Myers Squibb	Nivolumab	Human IgG4	PD1	Japan	O (Japan)	Melanoma
Merck	Pembrolizumab	Humanized IgG4	PD1	US	P, BT	Melanoma

Note: Table compiled from information publically available as of May 21, 2014. Abbreviations: BT, US breakthrough therapy designation; CD, cluster of differentiation; EU, European Union; FT, US fast track designation; GD, disialoganglioside; IL, interleukin; INN, international non-proprietary name; NA, not applicable; O, orphan drug designation; P, priority review by US Food and Drug Administration; PD, programmed cell death; S, standard review by US Food and Drug Administration; US, United States.