FDA Grants Pembrolizumab/Lenvatinib Breakthrough Designation for RCC

January 9, 2018 – The FDA has granted the combination of the PD-1 inhibitor pembrolizumab and the VEGF/FGF inhibitor lenvatinib a breakthrough therapy designation for the treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC). The designation is based on the RCC cohort of the multicenter, open-label phase Ib/II Study 111, in which patients treated with the combination had an objective response rate (ORR) of 63.3% (95% CI, 43-80) … (leggi tutto)