HLB’s hepatocellular carcinoma treatment ‘rivoceranib’ has now entered FDA’s review.

Yang-Gon Jin, Chairman of the HLB Group, announced on the morning of the 17th that “HLB’s US subsidiary Elevar received an ‘NDA Filing Acceptance’ letter from the FDA.”

Elevar submitted a new drug application (NDA) for rivoceranib on May 16 after completing a global Phase III study evaluating the efficacy and safety of rivoceranib+camrelizumab therapy.

The FDA assigned a target action date of May 16, 2024, under the Prescription Drug User Fee Act (PDUFA). Therefore, the decision will be made for the new drug within 10 months.

With the FDA’s acceptance of the NDA, t