Elevar liver cancer combo receives third FDA rejection

Elevar Therapeutics, a majority-owned subsidiary of South Korea's HLB (Kosdaq: 028300), has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application seeking approval of rivoceranib in combination with AiRuiKa (camrelizumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.

The FDA said the application could not be approved because of deficiencies identified during a current good manufacturing practice (cGMP) inspection of a manufacturing site listed in the rivoceranib application. Elevar said it is reviewing the agency's comments and plans to work closely with the FDA to determine the most appropriate path forward.