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Lilly gets fifth FDA approval for Cyramza

Eli Lilly’s Cyramza got its fifth FDA approval for in an advanced or metastatic cancer – this one for the second-line treatment of patients with hepatocellular carcinoma (HCC) who are AFP-High (AFP ≥400 ng/mL).

The FDA has also removed the boxed warning from the Cyramza labeling with this approval, Lilly said.

Andrew X. Zhu, M.D., 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 this is an important step in the treatment of this type carcinoma.

“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 disease and a poorer prognosis with increased angiogenesis.”

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