FDA approves Cyramza for hepatocellular carcinoma

On May 10, 2019, the US Food and Drug Administration approved Cyramza (ramucirumab) from US pharma major Eli Lilly (NSYE: LLY) as a single agent for hepatocellular carcinoma (HCC; liver cancer) in patients who have an alpha fetoprotein (AFP) of ≥ 400ng/mL and have been previously treated with sorafenib (Nexavar).

The approval was based on REACH‑2 (NCT02435433), a multinational, randomized, double-blind, placebo-controlled, multicenter study in 292 patients with advanced HCC with AFP ≥ 400ng/mL who had disease progression on or after sorafenib or who were intolerant. Patients were randomized (2:1) to receive ramucirumab 8 mg/kg plus best supportive care (BSC) or placebo plus BSC every 2 weeks as an intravenous infusion until disease progression or unacceptable toxicity.

The trial’s primary endpoint was overall survival (OS). The estimated median OS was 8.5 months (7.0, 10.6) for patients receiving ramucirumab and 7.3 months (5.4, 9.1) for those receiving placebo (HR 0.71; 95% CI: 0.53, 0.95; p=0.020).