Keytruda Receives New Indication for Liver Cancer
November 9, 2018 – The U.S. FDA has approved a new indication for Keytruda® (pembrolizumab), manufactured by Merck, to treat patients who have hepatocellular carcinoma and have previously been treated with sorafenib.
Hepatocellular carcinoma (HCC) is the most common form of liver cancer diagnosed in adults, accounting for approximately 75% of cases. It is often seen in individuals who have chronic liver disease, such as cirrhosis (liver scarring) due to Hepatitis B or Hepatitis C infection. In general, the five-year survival rates for patients with liver cancer are poor – 31% for localized disease, and 3% for liver cancer that has spread to distant parts of the body. Treatment options for advanced disease remain limited.
In clinical studies, 17% of patients treated with Keytruda responded. Of these patients, 89% had a duration of response lasting six months or more, with 56% of responses lasting for at least 12 months. Recommended dosing under the HCC indication is 200mg administered via intravenous (IV) infusion every three weeks.
The new HCC indication is Keytruda’s fourteenth since the drug was first approved in 2014.