FDA OKs Ramucirumab for Patients with AFP-High Hepatocellular Carcinoma
Ramucirumab (Cyramza, Eli Lilly) is approved as a single agent in patients with elevated alpha fetoprotein who have been previously treated with sorafenib.
Officials with the FDA have approved ramucirumab (Cyramza, Eli Lilly and Company) as a single agent in certain patients with hepatocellular carcinoma (HCC), according to a press release. Patients with HCC who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib are eligible for this treatment.
Approximately half of all patients with advanced HCC are AFP-high and these patients have a poor prognosis relative to the general HCC patient population, according to Eli Lilly. Despite recent advancements in treating HCC, there has been an unmet need for patients in this treatment setting.
The approval is based on data from the REACH-2 clinical trial evaluating the drug in 292 patients with advanced HCC with AFP ≥ 400 ng/mL who had disease progression on or after sorafenib or were intolerant. Patients received either ramucirumab 9 mg/kg plus best supportive care (BSC) or a placebo plus BSC every 2 weeks as an intravenous infusion until disease progression or unacceptable toxicity.
According to the data, the estimated median overall survival (OS) was 8.5 months for patients receiving ramucirumab compared with 7.3 months for those receiving a placebo (HR 0.71; 95% CI: 0.53, 0.95; p=0.020).
The REACH-2 study is the first positive phase 3 HCC trial in a biomarker-selected patient population, according to Eli Lilly.
“Advanced liver cancer is an aggressive disease that has a poor prognosis — and for those with elevated AFP levels, the prognosis is even more dismal,” Levi Garraway, MD, PhD, senior vice president of global development and medical affairs at Lilly Oncology, said in a previous statement about the REACH-2 trial results. “The expected survival of these patients is only a few months following first-line treatment if they don’t go onto second-line therapy.”
The most common adverse reactions observed in patients with HCC receiving ramucirumab were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites.
According to Lilly, the recommended dose for ramucirumab is 8 mg/kg administered intravenously every 2 weeks.
FDA approves ramucirumab for hepatocellular carcinoma [news release]. FDA. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ramucirumab-hepatocellular-carcinoma. Accessed May 10, 2019.
Lilly Announces Cyramza (ramucirumab) Phase 3 REACH-2 Study in Second-Line Hepatocellular Carcinoma Patients Met Overall Survival Endpoint [news release]. Eli Lilly and Company.