Eli Lilly and Company announced that the FDA approved Cyramza for second-line treatment of patients with advanced hepatocellular carcinoma and high alpha-fetoprotein levels, according to a company press release and an FDA release.
The FDA approval — the fifth for Cyramza — was based on results of a randomized control phase 3 trial of biomarker-selected patients with advanced HCC and alpha-fetoprotein levels of 400 ng/mL or higher who had previously been treated with Nexavar (sorafenib, Bayer).
“This approval of Cyramza is an important step forward in the treatment of advanced hepatocellular carcinoma,” Andrew X. Zhu, MD, from Massachusetts General Hospital Cancer Center and Harvard Medical School, and principal investigator of the REACH-2 trial, said in the press release. “While there have been some recent advances, there are still limited treatment options for people with this type of cancer and ... there was no treatment option specifically indicated for patients with increased alpha-fetoprotein concentrations.”
Compared with placebo in the phase 3 trial, researchers observed fewer deaths (75% vs. 78%) with longer overall survival (8.5 vs. 7.3 months) in patients treated with Cyramza (HR = 0.71; 0.53-0.95). Progression-free survival (HR = 0.45; 0.34-0.6) and overall response rate (4.6% vs. 1.1%) were also superior compared with placebo.
Additionally, the FDA removed boxed warning pertaining to hemorrhage, gastrointestinal perforation and impaired wound healing. The updated labeling continues to provide important information on these specific risks and other adverse events.
The most common adverse events from treatment with Cyramza compared with placebo include fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites.
“This new indication for Cyramza further reinforces Lilly’s ongoing commitment to delivering meaningful medicines that are tailored for people with advanced cancers and the physicians that work in partnership with them,” Anne White, president of Lilly Oncology, said in the press release. “Our work is focused on helping people who are living with cancer and Lilly is making strides in its efforts to develop precision medicine-based therapies for patients, to give them a fighting chance against their disease.”
Reference: www.lillyoncology.com; www.fda.gov