Eli Lilly gets USFDA nod for Cyramza to treat hepatocellular carcinoma
Eli Lilly’s Cyramza has a new string to its bow after the FDA approved it as a second-line treatment for certain liver cancer patients, and received a further boost as the FDA removed a boxed warning from its label.
The US regulator first approved Cyramza for cancer of the oesophagus in 2014, and since then Lilly has added further uses in gastric cancer after chemotherapy, an aggressive type of lung cancer, and as a second line treatment for colorectal cancer.
With these approvals Cyramza has been a steady performer for Lilly, and generated $198.3 million for the Indianopolis-based pharma in the first quarter of 2019, up 8% year-on-year.
The company will hope to build on this with the new indication in patients with hepatocellular carcinoma (HCC), who have alpha-fetoprotein (AFP) above 400ng/mL and have been treated with Bayer’s Nexavar (sorafenib).
AFP is a prognostic biomarker that can be assessed through a simple blood test, allowing doctors to select patients who may benefit from treatment and to monitor disease progression in advanced HCC.
Approval is based on the results from the REACH-2 study, the first positive phase 3 HCC trial in a biomarker-selected patient population. REACH-2 tested Cyramza against placebo in patients with HCC who have been treated with sorafenib and are AFP-High.
Andrew X. Zhu, director of liver cancer research at Massachusetts General Hospital Cancer Center, professor of medicine at Harvard Medical School and principal investigator of the REACH-2 trial, said: “While there have been some recent advances, there are still limited treatment options for people with this type of cancer and – until now – there was no treatment option specifically indicated for patients with increased alpha-fetoprotein concentrations. These patients can have more aggressive diseases and a poorer prognosis with increased angiogenesis.”
There was also good news for Lilly as in light of the new data, the FDA removed a boxed warning from the drug’s label highlighting risks of haemorrhage, gastrointestinal perforation, and impaired wound healing, although the drug’s label will continue to provide information on these issues as well as other adverse events.
Cyramza works by blocking the formation of blood vessels that feed tumours with oxygen, binding with vascular endothelial growth factor receptor 2, thus blocking binding of ligands that lead to tumour growth.
HCC is the most common form of liver cancer, which is the fourth-leading cause of cancer-related death worldwide.
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