July 10 (Reuters) – Elevar Therapeutics said on Friday that the U.S. FDA declined to approve its drug combination for a type of liver cancer, due to deficiencies identified during an inspection of a manufacturing site.
Elevar, majority owned by Korea’s HLB Co, had sought approval for rivoceranib and camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma — a type of liver cancer in which the tumor cannot be fully removed by surgery due to its size or location, or because it has spread to distant organs or tissues.
“The company is reviewing the contents of the letter and intends to work closely with the FDA to determine the appropriate path forward,” said CEO Dong-Gun Kim.
“We will engage with the FDA promptly to fully understand the agency’s feedback and determine the most effective path forward,” Kim added.
(Reporting by Puyaan Singh in Bengaluru; Editing by Diti Pujara)
Comments