July 10 (Reuters) – Elevar Therapeutics and Hengrui suffered a fresh setback on Friday after the U.S. FDA declined to approve their drug combination for a type of liver cancer, citing deficiencies at a manufacturing site.
The setback marks the FDA’s third rejection in as many years of rivoceranib and camrelizumab as a first-line treatment for advanced hepatocellular carcinoma (HCC).
Elevar, majority owned by Korea’s HLB Co, had sought approval in patients with unresectable or metastatic HCC — cases where the tumor cannot be surgically removed or has spread to other organs.
HCC is the most common type of liver cancer and typically develops in people with chronic liver inflammation from viral or non-viral causes, Elevar said.
“The company is reviewing the contents of the letter and intends to work closely with the FDA to determine the appropriate path forward,” said Elevar CEO Dong-Gun Kim.
The company added the Food and Drug Administration has previously acknowledged substantial clinical data supporting the application.
The latest rejection stems from a manufacturing site tied to the rivoceranib filing, whereas the FDA’s 2024 decision was driven by camrelizumab manufacturing concerns.
The drugs are approved in China to treat several cancers, including gastric and liver tumors. Camrelizumab is also approved there as a monotherapy.
Chinse drugmaker Hengrui holds the rights to commercialize camrelizumab in China and Korea and rivoceranib in China.
(Reporting by Puyaan Singh in Bengaluru; Editing by Diti Pujara and Vijay Kishore)
