. 2018 May;10(Suppl 13):S1564–S1580. doi: 10.21037/jtd.2018.01.131

Table 1. FDA and EMA approved indications for immune checkpoint inhibitors in advanced solid cancers.

Drug	Indications	Line	Primary endpoint	FDA approval	EMA approval
Ipilimumab	Melanoma	≥2^nd	OS	Approved	Approved
		1^st	ORR	Approved	Approved
		Any in combination with nivolumab	PFS	Approved	Approved
Nivolumab	Melanoma	≥2^nd	ORR	Approved	Approved
	Melanoma	1^st	OS	Approved	Approved
	NSCLC^¤	≥2^nd	OS	Approved	Approved
	RCC	≥2^nd	OS	Approved	Approved
	SCCHN	≥2^nd	OS	Approved	Approved
	UCC	≥2^nd	ORR	Approved	Approved
	MSI-H CRC	≥2^nd	ORR	Approved	–
	HCC	≥2^nd *	ORR	Approved	–
Pembrolizumab	Melanoma	≥2^nd	ORR	Approved	Approved
	Melanoma	1^st	OS	Approved	Approved
	NSCLC^¤	≥2^{nd †}	ORR	Approved	Approved
		1^{st ‡}	PFS	Approved	Approved
		1^st in combination with chemotherapy ^§	ORR	Approved	–
	SCCHN	≥2^nd	ORR	Approved	–
	UCC	≥2^nd	OS	Approved	Approved
	MSI-H any histology	≥2^nd	ORR	Approved	–
	Gastric/GEJ	≥2^nd	ORR	Approved	–
Atezolizumab	NSCLC^¤	≥2^nd	OS	Approved	Approved
Atezolizumab	UCC	≥2^nd	ORR	Approved	Approved
Durvalumab	UCC	≥2^nd	ORR	Approved	–
Avelumab	UCC	≥2^nd	ORR	Approved	–
Avelumab	Merkel carcinoma	≥2^nd	ORR	Approved	Approved

*, after progression to sorafenib; ^†, in patients with PD-L1 expression ≥1%; ^‡, in EGFR and ALK wild type patients with PD-L1 expression ≥50%; ^§, platinum-based chemotherapy; ^¤, both squamous and non-squamous histology; NSCLC, non-small cell lung cancer; RCC, renal cell carcinoma; UCC, urothelial carcinoma; CRC, colorectal cancer; MSI-H, microsatellite instability high; SCCHN, squamous cell carcinoma of the head and neck; GEJ, gastroesophageal junction; ORR, overall response rate; PFS, progression-free survival; OS, overall survival; FDA, Food and Drug Administration; EMA, European Medical Agency.