(Reuters) – Bristol Myers Squibb’s combination of its immunotherapies, Opdivo and Yervoy, to treat a type of liver cancer received U.S. regulatory approval, the drugmaker said on Wednesday.
The therapy received the Food and Drug Administration’s accelerated approval to treat patients with hepatocellular carcinoma, who have previously been administered sorafenib, the current standard of care. (https://reut.rs/2xoHuvv)
The accelerated approval program allows a speedier market entry to medicines that fill an unmet medical need for a serious condition, and further clinical trials may be required for final approval of the therapy.
The FDA approval is based on an early stage trial in which 33% of patients responded to the therapy.
“The incidence of liver cancer is rising in the United States…and today’s approval provides a new option for patients with HCC (hepatocellular carcinoma),” said Andrea Wilson, president Blue Faery: The Adrienne Wilson Liver Cancer Association.
HCC is the most common type of primary liver cancer and is more common in people who drink large amounts of alcohol and who have an accumulation of fat in the liver.
(Reporting by Trisha Roy in Bengaluru; Editing by Shailesh Kuber)