FDA Approves Nivolumab for Hepatocellular Carcinoma

September 22, 2017 – The FDA has granted an accelerated approval to nivolumab for the treatment of patients with hepatocellular carcinoma (HCC) following prior sorafenib, regardless of PD-L1 status. The approval is based on 154 patients enrolled in the phase I/II CheckMate-040 trial, in which the overall response rate (ORR) by blinded independent central review (BICR) was 18.2% per mRECIST criteria for patients who had previously been treated with … (leggi tutto)