Table 1.

Chronologic FDA approvals of novel immunotherapies.

Agent	Target/class	indication	Evidence	FDA approval date	Pivotal trial references
Ipilimumab	CTLA-4 Fully human MAb	Metastatic melanoma	OS	25 March 2011	(9, 10)
Pembrolizumab	PD-1 Humanized mAb	Metastatic melanoma	OS	4 Sept 2014	(99, 100)
Nivolumab	PD-1 Fully human MAb	Metastatic melanoma	OS	22 Dec 2014	(101, 102)
Nivolumab	PD-1 Fully human MAb	Stage IV NSCLC (squamous) Second line	OS	24 March 2015	(103)
Ipilimumab+Nivolumab (Combination)	CTLA-4 and PD-1 Fully human MAbs	Metastatic melanoma	PFS	30 September 2015	(32–34)
Pembrolizumab	PD-1 Humanized mAb	Stage IV NSCLC PD-L1+<50%	OS	2 October 2015	(104)
Nivolumab	PD-1 Fully human MAb	Stage IV NSCLC (adenocarcinoma) Second line	OS	9 October 2015	(105)
Tamoligene laherparepvec (T-vec)	HSV-1 replicative viral vector engineered to express GM-CSF	Locally advanced or metastatic melanoma accessible for intratumoral delivery.	OS	27 October 2015	(97)
Ipilimumab	CTLA-4 Fully human MAb	Surgically resectable melanoma	OS	28 October 2015	(106)
Nivolumab	PD-1 Fully human MAb	Renal cell carcinoma Second line	OS	23 November 2015	(11)