Table 2.

US Food and Drug Administration approved targeted therapy for renal cell carcinoma.

Agent, date approved	Study design, patient population	Primary endpoint	Results
Sorafenib December 2005	Randomized phase III, comparison to placebo; one prior therapy - cytokine	PFS	Median PFS 167 days versus 84 days
			HR 0.44 (0.35–0.55)
Sunitinib Accelerated approval January 2006	Two phase II studies in cytokine refractory patients	RR	34%; 36.5%
Regular approval February 2007	Randomized phase III, compared with IFN; no prior therapy	PFS	Median PFS 47 weeks versus 22 weeks
			HR 0.42 (0.32–0.54)
Temsirolimus May 2007	Randomized phase III, comparison to IFN; no prior therapy; poor risk features	OS	Median OS 10.9 months versus 7.3 mo
			HR 0.73 (0.58–0.92)
Everolimus March 2009	Randomized phase III compared with placebo; progression after prior TKI	PFS	Median PFS 4.9 months versus 1.9 months
			HR 0.33 (0.25–0.43)
Bevacizumab July 2009	Randomized phase III comparing bevacizumab + IFN with IFN alone	PFS	Median PFS 8.5 months versus 5.2 months (Rini) HR 0.71 (0.61–0.83)
	No prior therapy		Median PFS 10.2 months versus 5.4 months (Escudier)
			HR 0.60 (0.49–0.72)
			OS 18 months and 19.8 months
Pazopanib October 2009	Randomized phase III comparison to placebo; prior cytokine or no prior therapy	PFS	Median PFS 9.2 months versus 4.2 months, all patients
			HR 0.46 (0.34–0.62)
			Median PFS 11.1 months versus 2.8 months, no prior therapy
			HR 0.4 (0.27–0.60)
			Median PFS 7.4 months versus 4.2 months, prior cytokine
			HR 0.54 (0.35–0.84)
Axitinib January 2012	Phase III randomized, compared with sorafenib; at least one prior therapy	PFS	Median PFS 6.7 months versus 4.7 months, all patients
			HR 0.66 (0.54–0.81), all patients
			OS 20.1 months axitinib; 19.2 months sorafenib
			HR 0.969

HR, hazard ratio; IFN, interferon; OS, overall survival; PFS, progression-free survival; TKI, tyrosine kinase.